438 Pharmaceutical Manufacturing jobs in India
Quality Control Manager - Pharmaceutical Manufacturing
Posted 11 days ago
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Job Description
Key Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) in compliance with regulatory standards.
- Oversee all quality control activities, including raw material testing, in-process controls, and finished product release.
- Lead and mentor the Quality Control team, providing training and performance management.
- Ensure adherence to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- Review and approve batch records, validation protocols, and stability studies.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPA).
- Manage and maintain QC laboratory equipment, ensuring calibration and proper functioning.
- Conduct internal audits and participate in external regulatory inspections.
- Collaborate with Production, R&D, and Regulatory Affairs departments to ensure product quality.
- Stay updated on current pharmaceutical regulations and industry best practices.
- Promote a quality-focused culture throughout the manufacturing facility.
- Master's degree or Ph.D. in Pharmacy, Chemistry, Microbiology, or a related life science field.
- Minimum of 7-10 years of experience in Quality Control within the pharmaceutical industry, with at least 3 years in a managerial role.
- Extensive knowledge of GMP, GLP, ICH guidelines, and pharmaceutical regulatory requirements.
- Proven experience in setting up and managing a QC laboratory.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent leadership, team management, and communication abilities.
- Proficiency in using QC instrumentation and analytical techniques.
- Experience with audit preparation and regulatory submissions is a must.
Quality Control Analyst - Pharmaceutical Manufacturing
Posted 19 days ago
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Job Description
Responsibilities:
- Perform a variety of analytical tests on raw materials, in-process samples, and finished pharmaceutical products using established laboratory methods and instrumentation (e.g., HPLC, GC, UV-Vis Spectrophotometry).
- Analyze test results, compare them against specifications, and document findings accurately in compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Prepare and standardize reagents and solutions required for analytical testing.
- Maintain laboratory equipment, including calibration, validation, and routine performance checks.
- Investigate out-of-specification (OOS) results, identify root causes, and participate in corrective and preventive action (CAPA) initiatives.
- Contribute to the development and validation of new analytical methods.
- Review and approve batch records and associated quality control data.
- Collaborate with production, R&D, and regulatory affairs departments to address quality-related issues.
- Ensure compliance with all relevant pharmaceutical regulations (e.g., FDA, EMA, CDSCO).
- Maintain a clean and organized laboratory environment.
- Stay updated on current trends and advancements in pharmaceutical quality control and analytical techniques.
- Prepare and present quality control reports and data summaries.
- Participate in internal and external audits.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related life science discipline.
- Minimum of 3-5 years of experience in pharmaceutical quality control or a related analytical laboratory role.
- Hands-on experience with common analytical instruments such as HPLC, GC, FTIR, UV-Vis spectrophotometers, etc.
- Thorough understanding of GLP, GMP, and other relevant pharmaceutical quality standards.
- Proficiency in data analysis, interpretation, and reporting.
- Strong attention to detail and accuracy.
- Excellent organizational and time management skills.
- Good written and verbal communication skills.
- Ability to work independently and as part of a team.
- Familiarity with relevant pharmacopoeias (e.g., USP, BP, IP) is a plus.
- Experience with statistical analysis software is advantageous.
Senior Quality Control Inspector - Pharmaceutical Manufacturing
Posted 22 days ago
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Job Description
Key Responsibilities:
- Perform comprehensive quality control testing on raw materials, in-process samples, and finished pharmaceutical products.
- Conduct physical, chemical, and microbiological analyses according to established protocols and specifications.
- Ensure all laboratory activities comply with current Good Manufacturing Practices (cGMP) and relevant regulatory guidelines.
- Maintain accurate and detailed records of all tests performed, results obtained, and deviations encountered.
- Calibrate and maintain laboratory equipment, ensuring its proper functioning and suitability for use.
- Review batch records and production documentation to verify compliance with quality standards.
- Participate in the investigation of out-of-specification (OOS) results and product deviations.
- Implement and monitor Corrective and Preventive Actions (CAPA) to address quality issues.
- Contribute to the development and validation of new analytical methods.
- Support internal and external audits by providing necessary documentation and information.
- Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related life science field.
- Minimum of 5 years of experience in quality control or quality assurance within the pharmaceutical industry.
- Thorough understanding of cGMP regulations and quality control principles.
- Proficiency in various laboratory techniques and analytical instrumentation (e.g., HPLC, GC, spectroscopy).
- Experience with pharmaceutical manufacturing processes and quality systems.
- Excellent attention to detail and accuracy in testing and documentation.
- Strong organizational and record-keeping skills.
- Effective communication and interpersonal abilities.
- Ability to work independently and as part of a team in a laboratory setting.
Automation Engineer – Pharmaceutical Manufacturing
Posted today
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Job Description
Job Title: Senior Automation Engineer Trainer – Pharmaceutical Manufacturing
Location: Remote
Experience: 10+ years
Industry: Pharmaceutical / Biotech Manufacturing
Job Summary:
The Senior Automation Engineer Trainer is responsible for driving automation initiatives across pharmaceutical manufacturing systems, ensuring compliance with GMP, and enhancing equipment reliability and process efficiency. This role involves overseeing automation design, programming, validation, and maintenance of PLC, SCADA, and related control systems used in production and utility areas.
Key Responsibilities:
- Managed automation systems supporting production, utilities, and cleanroom environments in compliance with GMP and regulatory requirements.
- Developed, modified, and optimized control logic for PLC, HMI, and SCADA systems (Siemens, Allen-Bradley, DeltaV, or equivalent).
- Supported the design, configuration, and integration of new automated equipment and systems into existing production lines.
- Performed troubleshooting and root cause analysis of automation and instrumentation failures to minimize downtime.
- Executed system upgrades, patches, and changes following change control procedures and validation standards (GAMP 5).
- Prepared and reviewed technical documentation including URS, FDS, FAT, SAT, IQ/OQ/PQ, and SOPs.
- Ensured data integrity and compliance with 21 CFR Part 11 for electronic records and automation systems.
- Collaborated with cross-functional teams (Engineering, QA, Validation, and Manufacturing) for project execution and continuous improvement.
- Guided junior engineers and technicians in automation programming, troubleshooting, and documentation practices.
Bioprocess Engineer - Pharmaceutical Manufacturing
Posted 5 days ago
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Job Description
Key Responsibilities:
- Design, develop, and scale up biopharmaceutical manufacturing processes.
- Optimize bioreactor performance, including media formulation, inoculation strategies, and operating parameters.
- Oversee downstream purification processes such as filtration, chromatography, and viral inactivation.
- Validate new equipment and processes according to cGMP guidelines.
- Troubleshoot process deviations and implement corrective and preventative actions (CAPAs).
- Monitor process performance using data acquisition systems and statistical process control.
- Author and review technical documents, including batch records, SOPs, and validation protocols.
- Collaborate with cross-functional teams to ensure seamless technology transfer from R&D to manufacturing.
- Ensure compliance with all relevant regulatory requirements and quality standards.
- Identify and implement process improvements to enhance efficiency, yield, and product quality.
Qualifications:
- Bachelor's or Master's degree in Biochemical Engineering, Chemical Engineering, or a related field.
- Minimum of 3-5 years of experience in biopharmaceutical process development or manufacturing.
- Hands-on experience with microbial fermentation and/or mammalian cell culture processes.
- Proficiency in downstream processing techniques (e.g., chromatography, tangential flow filtration).
- Understanding of cGMP regulations and validation principles.
- Strong analytical and problem-solving skills.
- Excellent written and oral communication skills.
- Ability to work effectively in a team environment and independently.
- Experience with process modeling and simulation software is a plus.
Automation Engineer Trainer – Pharmaceutical Manufacturing
Posted today
Job Viewed
Job Description
Job Title: Senior Automation Engineer Trainer – Pharmaceutical Manufacturing
Location: Remote
Experience: 10+ years
Industry: Pharmaceutical / Biotech Manufacturing
Job Summary:
The Senior Automation Engineer Trainer is responsible for driving automation initiatives across pharmaceutical manufacturing systems, ensuring compliance with GMP, and enhancing equipment reliability and process efficiency. This role involves overseeing automation design, programming, validation, and maintenance of PLC, SCADA, and related control systems used in production and utility areas.
Key Responsibilities:
- Managed automation systems supporting production, utilities, and cleanroom environments in compliance with GMP and regulatory requirements.
- Developed, modified, and optimized control logic for PLC, HMI, and SCADA systems (Siemens, Allen-Bradley, DeltaV, or equivalent).
- Supported the design, configuration, and integration of new automated equipment and systems into existing production lines.
- Performed troubleshooting and root cause analysis of automation and instrumentation failures to minimize downtime.
- Executed system upgrades, patches, and changes following change control procedures and validation standards (GAMP 5).
- Prepared and reviewed technical documentation including URS, FDS, FAT, SAT, IQ/OQ/PQ, and SOPs.
- Ensured data integrity and compliance with 21 CFR Part 11 for electronic records and automation systems.
- Collaborated with cross-functional teams (Engineering, QA, Validation, and Manufacturing) for project execution and continuous improvement.
- Guided junior engineers and technicians in automation programming, troubleshooting, and documentation practices.
Senior Process Engineer - Pharmaceutical Manufacturing
Posted today
Job Viewed
Job Description
As a Senior Process Engineer, you will be responsible for the continuous improvement of existing manufacturing processes, troubleshooting operational issues, and leading the design and implementation of new process technologies. You will conduct process hazard analyses, develop Standard Operating Procedures (SOPs), and ensure adherence to all regulatory requirements. Collaboration with R&D, Quality Assurance, Production, and Maintenance teams will be critical to achieving operational excellence. This position requires a proactive approach to identifying and implementing process enhancements that improve yield, reduce costs, and enhance product quality. You will also play a key role in validation activities, including IQ/OQ/PQ of new equipment and processes. The ability to lead cross-functional teams and manage projects effectively is crucial.
Responsibilities:
- Design, develop, and optimize chemical and pharmaceutical manufacturing processes.
- Troubleshoot and resolve process-related issues to ensure continuous operation and product quality.
- Lead process improvement initiatives to enhance efficiency, yield, and cost-effectiveness.
- Conduct process hazard analyses (PHAs) and implement safety improvements.
- Develop and revise Standard Operating Procedures (SOPs) and batch records.
- Oversee and participate in the validation of new equipment and processes (IQ/OQ/PQ).
- Collaborate with R&D to scale up new products and processes from laboratory to commercial production.
- Ensure all processes comply with GMP, FDA, and other relevant regulatory guidelines.
- Work closely with Production, Quality Assurance, and Maintenance departments to address operational challenges.
- Train production personnel on new processes and equipment.
- Analyze process data to identify trends, root causes of deviations, and opportunities for optimization.
- Prepare technical reports, process documentation, and presentations.
- Stay current with industry best practices and emerging technologies in pharmaceutical manufacturing.
- Manage process engineering projects, including scope, budget, and timelines.
- Bachelor's or Master's degree in Chemical Engineering or a related discipline.
- Minimum of 6-8 years of experience in process engineering within the pharmaceutical or biotechnology industry.
- In-depth knowledge of GMP regulations and validation principles.
- Experience with various manufacturing unit operations (e.g., reaction, filtration, drying, granulation, tablet compression, sterile filling).
- Proficiency in process simulation software and data analysis tools.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent written and verbal communication skills.
- Proven ability to lead projects and cross-functional teams.
- Experience with process safety management (PSM).
- Familiarity with Lean Manufacturing or Six Sigma methodologies is a plus.
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Senior Pharmaceutical Manufacturing Operations Lead
Posted today
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Job Description
Responsibilities:
- Lead and manage day-to-day pharmaceutical manufacturing operations, ensuring compliance with cGMP, regulatory requirements, and company policies.
- Develop and implement strategic plans to enhance manufacturing efficiency, throughput, and cost-effectiveness.
- Oversee the production lifecycle from raw material receiving through to final product packaging and release.
- Implement and champion lean manufacturing principles and continuous improvement initiatives (e.g., Six Sigma).
- Manage production schedules, resource allocation, and operational budgets effectively.
- Ensure robust quality control and quality assurance processes are integrated into all manufacturing activities.
- Lead, mentor, and develop a high-performing manufacturing team, fostering a culture of accountability and continuous learning.
- Drive process validation and optimization projects to improve yield, reduce waste, and enhance product quality.
- Collaborate closely with R&D, Engineering, Supply Chain, and Quality Assurance departments to ensure seamless operations.
- Develop and maintain strong relationships with key equipment vendors and service providers.
- Oversee and manage operational health and safety programs to ensure a safe working environment.
- Prepare and present operational performance reports, key metrics, and strategic recommendations to senior leadership.
- Master's degree in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, or a related technical field.
- Minimum of 10 years of progressive experience in pharmaceutical manufacturing operations, with a significant track record in leadership roles.
- In-depth knowledge of cGMP regulations, regulatory guidelines (e.g., FDA, EMA, ICH), and pharmaceutical manufacturing best practices.
- Proven experience in leading large-scale manufacturing operations and managing complex production processes.
- Strong understanding of process validation, sterile manufacturing, API production, or finished dosage forms.
- Expertise in implementing lean manufacturing principles and driving operational excellence.
- Exceptional leadership, communication, problem-solving, and decision-making skills.
- Demonstrated ability to manage budgets and P&L responsibilities.
- Experience with process automation, MES, and ERP systems.
- Ability to thrive and lead effectively in a fully remote work environment.
Senior Process Engineer - Pharmaceutical Manufacturing
Posted 1 day ago
Job Viewed
Job Description
Key Responsibilities:
- Design, develop, and optimize manufacturing processes for pharmaceutical products, ensuring compliance with cGMP and other regulatory standards.
- Analyze process data to identify inefficiencies, troubleshoot issues, and implement corrective actions.
- Lead process validation activities, including protocol development, execution, and reporting.
- Develop and maintain Standard Operating Procedures (SOPs) for all manufacturing processes.
- Collaborate with R&D, Quality Assurance, and Production teams to ensure seamless technology transfer and scale-up.
- Implement process improvements to enhance yield, reduce waste, and lower manufacturing costs.
- Conduct risk assessments and implement mitigation strategies for process-related hazards.
- Provide technical expertise and support to manufacturing operations.
- Stay current with industry trends, new technologies, and best practices in pharmaceutical manufacturing.
- Develop and deliver training programs to production personnel on process operations and safety.
- Contribute to the design and qualification of new equipment and facility modifications.
- Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, or a related field.
- A minimum of 7 years of experience in process engineering within the pharmaceutical or biopharmaceutical industry.
- Strong knowledge of cGMP, FDA regulations, and other relevant industry standards.
- Proven experience in process design, scale-up, validation, and optimization.
- Excellent analytical and problem-solving skills, with a data-driven approach.
- Proficiency in process simulation software (e.g., Aspen Plus, HYSYS) is highly desirable.
- Strong understanding of unit operations common in pharmaceutical manufacturing (e.g., filtration, crystallization, drying, fermentation).
- Excellent written and verbal communication skills, with the ability to document technical information clearly and concisely.
- Ability to work independently and collaboratively in a remote team environment.
- Experience with Lean Manufacturing or Six Sigma methodologies is a plus.
Senior Process Engineer - Pharmaceutical Manufacturing
Posted 1 day ago
Job Viewed
Job Description
Key Responsibilities:
- Lead the design, development, and implementation of new manufacturing processes and the optimization of existing ones.
- Conduct detailed process analysis, identify bottlenecks, and develop solutions to improve yield, efficiency, and product quality.
- Develop and execute process validation protocols, ensuring compliance with regulatory requirements (e.g., FDA, EMA).
- Troubleshoot and resolve complex process-related issues, ensuring minimal disruption to production schedules.
- Collaborate with cross-functional teams, including Quality Assurance, R&D, and Operations, to support process development and scale-up activities.
- Prepare technical documentation, including process flow diagrams, P&IDs, and standard operating procedures (SOPs).
- Stay updated on industry best practices, new technologies, and regulatory changes relevant to pharmaceutical manufacturing.
- Provide technical training and mentorship to junior engineers and operators.
- Ensure all processes adhere to safety standards and environmental regulations.
- Bachelor's or Master's degree in Chemical Engineering or a related engineering discipline.
- Minimum of 7 years of experience in process engineering, preferably within the pharmaceutical or biotech industry.
- Proven experience with process design, scale-up, validation, and troubleshooting in a GMP environment.
- In-depth knowledge of relevant manufacturing technologies and equipment (e.g., reactors, filtration systems, drying equipment).
- Strong understanding of regulatory requirements and quality systems in the pharmaceutical industry.
- Excellent analytical, problem-solving, and decision-making skills.
- Proficiency in process simulation software and data analysis tools.
- Strong project management skills and the ability to manage multiple priorities.
- Effective communication and interpersonal skills, with the ability to collaborate effectively with diverse teams.