87 Quality Assurance Manager jobs in Dlf Qe
Quality Assurance Manager
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Company Description
DYNAMIC TRANSMISSION LIMITED is a machinery company based in Haryana, India, specializing in high-quality transmission technologies. Located at IMT Manesar Gurgaon, the company is known for its commitment to innovation and excellence. DYNAMIC TRANSMISSION LIMITED serves a diverse clientele, providing robust and efficient machinery solutions.
Role Description
This is a full-time on-site role for a Quality Assurance Manager based in Manesar. The Quality Assurance Manager will oversee the quality assurance processes, including the development and implementation of quality management systems. Responsibilities include conducting audits, managing inspection activities, and coordinating with various departments to ensure compliance with industry standards. The role also involves identifying areas for improvement, developing quality control policies, and training staff on quality assurance procedures.
Qualifications
- Quality Management Systems, Quality Control, and Process Improvement skills
- Experience in conducting audits and managing inspection activities
- Strong analytical and problem-solving skills
- Excellent communication and coordination skills
- Ability to work collaboratively with different departments
- Bachelor's degree in Engineering, Quality Assurance, or related field
- Relevant certifications such as Six Sigma or ISO are a plus
- Experience in the machinery or manufacturing industry is advantageous
Pharmaceutical Quality Assurance Manager
Posted 1 day ago
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Senior Pharmaceutical Quality Assurance Manager
Posted 1 day ago
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Job Description
Responsibilities:
- Develop, implement, and maintain a robust Quality Management System (QMS) in compliance with cGMP, ICH guidelines, and other relevant regulatory standards.
- Oversee all aspects of Quality Assurance, including batch record review, deviation management, CAPA implementation, change control, and OOS investigations.
- Lead and manage the QA team, providing mentorship, training, and performance evaluations.
- Conduct internal audits and support external audits by regulatory agencies (e.g., FDA, EMA) and customers.
- Ensure that all pharmaceutical products manufactured meet predefined quality specifications and regulatory requirements.
- Manage vendor qualification and auditing processes to ensure the quality of procured materials and services.
- Review and approve validation protocols and reports for manufacturing processes, equipment, and analytical methods.
- Monitor key quality metrics and performance indicators, providing regular reports to senior management.
- Contribute to regulatory submissions and respond to inquiries from health authorities.
- Drive continuous improvement initiatives within the QA department and manufacturing operations.
- Stay updated on evolving regulatory landscapes and industry best practices in pharmaceutical quality assurance.
- Manage product recalls and complaints effectively, ensuring timely resolution and communication.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 8-10 years of progressive experience in Pharmaceutical Quality Assurance and Quality Control.
- Extensive knowledge of cGMP, GLP, GCP, and international pharmaceutical regulatory requirements.
- Proven experience in managing QMS, conducting audits, and leading regulatory inspections.
- Strong leadership, team management, and interpersonal skills.
- Excellent analytical, problem-solving, and decision-making abilities.
- Proficient in documentation, validation, and investigation processes within the pharmaceutical industry.
- Effective communication skills, both written and verbal, with the ability to interact with regulatory bodies and senior management.
- Experience with sterile manufacturing and biologics is a significant advantage.
- Detail-oriented with a strong commitment to quality and compliance.
Senior Pharmaceutical Quality Assurance Manager
Posted 1 day ago
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Key responsibilities include developing, maintaining, and improving quality assurance procedures, conducting internal audits, and managing external regulatory inspections. You will lead a team of QA professionals, providing mentorship and ensuring adherence to quality policies. The role involves reviewing and approving batch records, validation protocols, and change controls. You will also play a key role in deviation investigations, CAPA management, and risk assessments. The Senior QA Manager will collaborate with various departments, including Manufacturing, R&D, and Regulatory Affairs, to ensure product quality and compliance throughout the product lifecycle.
A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field is required. A Master's degree is preferred. A minimum of 8-10 years of progressive experience in Quality Assurance within the pharmaceutical industry is essential. Demonstrated experience in managing QA operations and leading QA teams is mandatory. Strong knowledge of pharmaceutical regulatory affairs and a proven track record in successfully managing audits and inspections are critical. Excellent analytical, problem-solving, and decision-making skills are necessary. Outstanding communication, interpersonal, and leadership abilities are required to effectively manage the team and interact with cross-functional departments and regulatory authorities. This is an excellent opportunity to make a significant impact on product quality and patient safety within a dynamic and growing pharmaceutical organization. The candidate must demonstrate a commitment to continuous improvement and maintaining the highest standards of quality.
Senior Pharmaceutical Quality Assurance Manager
Posted 1 day ago
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Key Responsibilities:
- Develop, implement, and maintain robust Quality Management Systems (QMS) in compliance with global regulatory requirements (e.g., FDA, EMA, WHO GMP).
- Lead and manage internal and external audits, including preparation, execution, and follow-up on audit findings.
- Oversee the batch record review and release process, ensuring product quality and compliance.
- Manage deviation investigations, CAPA (Corrective and Preventive Actions), and change control processes.
- Develop and conduct quality training programs for personnel involved in manufacturing, quality control, and other relevant departments.
- Review and approve critical quality documents, including SOPs, validation protocols, and specifications.
- Monitor and analyze quality metrics and trends, identifying areas for continuous improvement.
- Act as a key liaison with regulatory agencies during inspections and inquiries.
- Ensure that all manufacturing and testing activities adhere to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- Manage a team of Quality Assurance professionals, providing guidance, mentorship, and performance management.
- Participate in new product development and lifecycle management activities from a quality perspective.
- Stay current with evolving regulatory guidelines and industry best practices in pharmaceutical quality assurance.
Qualifications:
- Master's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field.
- 8+ years of progressive experience in pharmaceutical Quality Assurance/Quality Control, with a strong focus on GMP environments.
- In-depth knowledge of international regulatory requirements (FDA, EMA, CDSCO, etc.).
- Proven experience in managing QMS, conducting audits, and leading investigations (deviations, CAPA).
- Excellent understanding of pharmaceutical manufacturing processes, validation, and documentation.
- Strong leadership and team management skills, with the ability to motivate and develop staff.
- Exceptional analytical, problem-solving, and decision-making abilities.
- Outstanding written and verbal communication skills, with the ability to communicate effectively with cross-functional teams and regulatory bodies.
- Experience with electronic QMS is a significant advantage.
- Ability to work effectively in a hybrid work model, balancing remote tasks with essential on-site responsibilities.
This hybrid role is based in Gurugram, Haryana, IN , offering a dynamic work environment.
Lead Quality Assurance Manager (Manufacturing)
Posted 1 day ago
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Responsibilities:
- Lead and manage the Quality Assurance department, including team development and performance management.
- Develop, implement, and maintain the company's Quality Management System (QMS).
- Oversee all quality control activities throughout the manufacturing process, from incoming materials to final product inspection.
- Establish and monitor key quality metrics and performance indicators (KPIs).
- Implement and utilize Statistical Process Control (SPC) methods to monitor and improve processes.
- Conduct internal audits and ensure compliance with relevant quality standards (e.g., ISO 9001).
- Manage customer complaints and implement effective corrective and preventive actions (CAPA).
- Collaborate with R&D, Production, and Engineering teams to resolve quality issues and improve product design.
- Ensure all products meet established specifications and regulatory requirements.
- Train and mentor QA personnel on quality principles and procedures.
- Drive continuous improvement initiatives to enhance product quality and manufacturing efficiency.
- Manage supplier quality and conduct supplier audits as necessary.
- Bachelor's degree in Engineering (Mechanical, Industrial, or related field), or equivalent practical experience.
- Minimum of 7 years of progressive experience in Quality Assurance within the manufacturing industry.
- Proven experience in implementing and managing QMS, preferably with ISO 9001 certification.
- Strong understanding of quality control tools and techniques (SPC, FMEA, root cause analysis).
- Demonstrated leadership and team management skills.
- Excellent analytical, problem-solving, and decision-making abilities.
- Strong communication, negotiation, and interpersonal skills.
- Ability to work effectively in a hybrid work environment, balancing remote and on-site responsibilities.
Senior Pharmaceutical Quality Assurance Manager
Posted 1 day ago
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Senior Pharmaceutical Quality Assurance Manager
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Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS).
- Ensure compliance with GxP regulations (GMP, GCP, GLP) and other relevant guidelines.
- Oversee and manage all quality control activities.
- Plan, conduct, and manage internal and external audits.
- Lead deviation investigations and implement effective CAPAs.
- Review and approve validation protocols and reports.
- Manage regulatory submissions and interactions with health authorities.
- Train and mentor QA personnel.
- Monitor quality metrics and drive continuous improvement initiatives.
- Ensure product quality and patient safety throughout the product lifecycle.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 8 years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of GxP regulations and guidelines.
- Proven experience in developing and managing QMS.
- Strong expertise in audit management, deviation investigation, and CAPA processes.
- Excellent leadership, team management, and communication skills.
- Strong analytical and problem-solving abilities.
- Experience with regulatory inspections and submissions.
- Ability to work effectively in a highly regulated environment.
- Familiarity with pharmaceutical manufacturing processes.
Senior Pharmaceutical Quality Assurance Manager
Posted 1 day ago
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Key Responsibilities:
- Develop, implement, and manage comprehensive Quality Assurance (QA) programs and systems for pharmaceutical products.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).
- Oversee and conduct internal and external audits to assess compliance and identify areas for improvement.
- Manage the deviation, CAPA (Corrective and Preventive Action), and change control systems.
- Review and approve batch records, validation protocols, and reports.
- Lead and mentor a team of QA professionals, fostering a culture of quality and continuous improvement.
- Collaborate with R&D, manufacturing, regulatory affairs, and other departments to ensure product quality and regulatory adherence.
- Develop and implement quality training programs for relevant personnel.
- Monitor industry trends, regulatory updates, and best practices in pharmaceutical quality assurance.
- Manage vendor qualification and ensure the quality of supplied materials and services.
- Lead cross-functional teams in resolving quality-related issues and implementing corrective actions.
- Prepare and present quality metrics and reports to senior management.
- Ensure the integrity and security of all quality-related data and documentation.
- Participate in regulatory inspections and respond to agency inquiries.
- Contribute to the development and improvement of Standard Operating Procedures (SOPs).
- Oversee the product release process, ensuring all quality requirements are met.
- Manage risk assessment and mitigation strategies related to product quality.
- Master's or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 10 years of progressive experience in pharmaceutical Quality Assurance and Quality Control.
- In-depth knowledge of cGMP, GLP, GCP, and relevant international regulatory guidelines (FDA, EMA, ICH, CDSCO).
- Proven experience in leading and managing QA teams.
- Strong understanding of pharmaceutical manufacturing processes, validation, and analytical testing.
- Excellent leadership, communication, and interpersonal skills.
- Strong analytical, problem-solving, and decision-making abilities.
- Experience with regulatory audits and inspections.
- Proficiency in quality management software and systems.
- Ability to work effectively in a hybrid work environment and collaborate across departments.
- Exceptional attention to detail and commitment to maintaining high quality standards.
Senior Pharmaceutical Quality Assurance Manager - Remote
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