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Job Title: Sr. Manager - Quality

Location: Delhi, India

Status: Full-Time

About PharmaSecure

PharmaSecure is a global track-and-trace, product authentication, and consumer engagement company that has helped protect over 8 billion packages through its technology-enabled solutions on hundreds of manufacturing lines. The codes printed are generated using its patented, encryption-based algorithm that provides unmatched security.

It has a proven track record of implementing minimal changes to the existing manufacturing process and negligible downtime of manufacturing lines by providing a solution that seamlessly integrates into the existing operations.

It’s proven serialization capabilities have enabled large pharmaceutical companies to meet different traceability requirements, as it ensures that pharma manufacturers exporting to various countries maintain regulatory compliances.

Other than being experts in global track-and-trace, product authentication, and consumer engagement, PharmaSecure is also an OEM for efficient machines to provide a full suite of software and hardware solutions under one umbrella.

Overview of Role

The Senior Manager – Quality will be responsible for ensuring the quality and compliance of software applications, IT systems, and related processes in alignment with regulatory requirements in the pharmaceutical sector. The role involves testing, validating, and verifying that all systems meet industry standards, including GxP compliance, 21 CFR Part 11, and other applicable regulations. The candidate should have a keen eye for detail, a strong understanding of pharma industry guidelines, and experience in software testing and validation.

Principal Responsibilities and Accountabilities

• Software Testing & Validation :
• Design and/or review manual and automated test cases for IT systems.
• Perform validation of pharma-related IT systems as per GMP guidelines.
• Ensure compliance with 21 CFR Part 11 and other global pharmaceutical regulatory standards.
• Ensure testing for all IT systems and applications is in-line with PhrmaSecure QMS.
• Supervise Manage defect tracking and resolution with development teams.
• Documentation :
• Prepare/Review validation documentation, including Test Plans, Test Scripts, Validation Protocols, and Reports (IQ/OQ/PQ).
• Maintain records of test results, issues identified, and corrective actions.
• Assist in maintaining Standard Operating Procedures (SOPs) and ensuring they are followed during testing and validation activities.
• Regulatory Compliance :
• Ensure IT systems and processes adhere to industry-specific regulatory standards (GxP, GMP, GAMP 5, and Data Integrity requirements) and maintain continuous compliance.
• Oversee both QA and Regulatory Affairs responsibilities to ensure alignment with evolving pharmaceutical and IT regulations.
• Act as the primary liaison for internal and external audits, ensuring all IT systems meet regulatory and compliance standards.
• Stay updated on regulatory changes affecting pharma IT systems and incorporate new requirements into QA and regulatory processes.
• Risk Management :
• Conduct risk assessments and develop mitigation strategies for IT systems.
• Identify potential risks and issues early in the development lifecycle to prevent system failures post-deployment.
• Collaboration & Support :
• Work closely with cross-functional teams (IT, Development, Manufacturing, Regulatory, etc.) to ensure a smooth transition of systems from development to production.
• Provide training and support to end-users for validated IT systems.
• Assist with internal and external audits, ensuring IT QA compliance is maintained.

Competencies

• Fluency in English.
• Excellent written and verbal communication skills.
• Excellent teamwork skills.
• Excellent attention to detail, quality and control.
• Proven ability to influence cross-functional teams without formal authority.

Required experience and knowledge

• 10 plus years of experience in IT Quality Assurance, preferably in the pharmaceutical or life sciences sector.
• Proven track record of validating GxP-compliant systems in a regulated environment.
• Familiarity with GAMP 5, 21 CFR Part 11, Data Integrity, and other relevant pharma regulations.
• Bachelor's or Master's degree in Information Technology, Computer Science, or a related field.
• Certifications like ISTQB, Six Sigma, or relevant QA certifications are a plus.
• Hands-on experience with test management tools (JIRA, HP ALM, etc.).
• Knowledge of SQL and scripting for database and application testing.
• Familiarity with automated testing tools (Selenium, QTP, etc.).
• Experience with ISO standards 9001 and 27001.
• Knowledge of Pharma machines validation will be an added advantage.

Compensation

Candidates that meet all the above requirements will be considered for competitive compensation commensurate with their experience.

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with global regulations.
• Oversee and manage all QA activities, including batch record review, release, deviation investigations, CAPA, and change control.
• Lead internal audits and host regulatory agency inspections (e.g., FDA, EMA) and customer audits.
• Ensure compliance with Good Manufacturing Practices (GMP) and other relevant industry standards.
• Develop and execute validation master plans and protocols for equipment, processes, and systems.
• Review and approve product quality related documentation, ensuring accuracy and completeness.
• Manage and mentor a team of Quality Assurance professionals, fostering their development and performance.
• Collaborate with R&D, Manufacturing, and Regulatory Affairs to ensure quality is built into products and processes.
• Drive continuous improvement initiatives within the QA function to enhance efficiency and compliance.
• Stay updated on evolving regulatory requirements and industry best practices.

• Master's degree or Ph.D. in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related life science field.
• Minimum of 8-10 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• Extensive knowledge of GMP, ICH guidelines, and global 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.
• Exceptional written and verbal communication skills.
• Ability to work independently and effectively in a fully remote environment.

• Develop, implement, and manage the company's Quality Management System (QMS) in compliance with global pharmaceutical regulations (e.g., FDA, EMA, WHO).
• Oversee and ensure adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).
• Lead and mentor the Quality Assurance team, fostering a culture of quality and continuous improvement.
• Conduct internal audits and support external regulatory inspections and audits from health authorities.
• Review and approve batch records, validation protocols, and reports.
• Manage deviations, investigations (CAPA), change controls, and risk assessments.
• Ensure that all pharmaceutical products meet established quality standards and specifications.
• Collaborate with R&D, Manufacturing, Regulatory Affairs, and other departments to resolve quality issues and drive product quality improvements.
• Stay updated on evolving regulatory requirements and industry best practices.
• Develop and deliver quality training programs to relevant personnel.
• Manage vendor qualification and ongoing supplier quality agreements.
• Prepare and present quality metrics and reports to senior management.

• Master's or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 10-15 years of progressive experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry.
• Deep understanding of pharmaceutical manufacturing processes, quality control, and regulatory compliance.
• Proven experience in managing QMS, conducting audits, and successfully navigating regulatory inspections.
• Strong knowledge of GMP, ICH guidelines, and other relevant international regulatory standards.
• Excellent leadership, team management, and interpersonal skills.
• Exceptional analytical, problem-solving, and decision-making abilities.
• Superior written and verbal communication skills, with the ability to present complex information clearly.
• Proficiency in using quality management software and tools.
• Ability to work independently and effectively manage multiple priorities in a remote setting.
• Commitment to upholding the highest ethical and quality standards.

• Develop, implement, and maintain the company's Quality Management System (QMS) to ensure compliance with all relevant pharmaceutical regulations and industry best practices.
• Oversee all QA activities, including batch record review and release, deviation management, CAPA implementation, change control, and complaint handling.
• Conduct regular internal audits and participate in external audits (regulatory inspections and client audits).
• Ensure all manufacturing processes adhere to Good Manufacturing Practices (GMP).
• Manage and mentor the Quality Assurance team, providing training and development opportunities.
• Review and approve validation protocols and reports for equipment, processes, and analytical methods.
• Collaborate with the Quality Control (QC) department to ensure timely and accurate testing of raw materials, intermediates, and finished products.
• Work closely with Production, R&D, and Regulatory Affairs to resolve quality issues and implement corrective actions.
• Stay updated on the latest regulatory requirements and industry trends in pharmaceutical quality assurance.
• Prepare and present quality metrics and reports to senior management.
• Lead continuous improvement initiatives to enhance product quality and manufacturing efficiency.
• Ensure proper documentation control and record-keeping practices are maintained.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Microbiology, or a related life science field.
• A minimum of 8 years of experience in Quality Assurance within the pharmaceutical industry.
• In-depth knowledge of GMP regulations, ICH guidelines, and other relevant pharmaceutical quality standards.
• Proven experience in managing QMS, batch record review, deviations, CAPAs, and change control.
• Strong leadership and team management skills.
• Excellent analytical, problem-solving, and decision-making abilities.
• Exceptional attention to detail and commitment to accuracy.
• Strong written and verbal communication skills, with the ability to effectively interact with regulatory agencies and internal stakeholders.
• Experience with pharmaceutical manufacturing processes and quality control testing.
• Must be able to work on-site in Delhi .

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• 8+ years of experience in pharmaceutical quality assurance or quality control.
• In-depth knowledge of GMP, ICH guidelines, and other relevant regulatory requirements.
• Proven experience in managing QMS, audits, deviations, and CAPA systems.
• Experience in leading and developing a QA team.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent written and verbal communication skills.
• Familiarity with pharmaceutical manufacturing processes and validation principles.

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with global regulatory standards (e.g., FDA, EMA, WHO).
• Oversee and manage all QA activities, including batch record review, deviation management, CAPA (Corrective and Preventive Actions), and change control.
• Conduct internal and external audits of manufacturing sites, contract manufacturers, and suppliers to ensure compliance.
• Prepare for and host regulatory inspections, acting as a primary point of contact.
• Review and approve validation protocols and reports for manufacturing processes, equipment, and analytical methods.
• Develop and deliver training programs on quality assurance principles and regulatory requirements.
• Manage product quality complaints and ensure timely investigation and resolution.
• Analyze quality data to identify trends, root causes of issues, and opportunities for improvement.
• Collaborate closely with R&D, manufacturing, regulatory affairs, and other departments to ensure quality is integrated throughout the product lifecycle.
• Stay current with evolving regulatory requirements and industry best practices in pharmaceutical quality assurance.
• Lead cross-functional teams to address quality-related challenges and implement corrective actions.
• Maintain all quality-related documentation, ensuring accuracy, completeness, and accessibility.
• Develop and manage departmental budgets and resources effectively for a remote team.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life sciences field.
• Minimum of 8 years of progressive experience in pharmaceutical Quality Assurance, with at least 3 years in a managerial role.
• In-depth knowledge of cGMP, ICH guidelines, and other relevant global regulatory requirements.
• Proven experience in managing QMS, conducting audits, and leading regulatory inspections.
• Strong understanding of pharmaceutical manufacturing processes, validation, and analytical testing.
• Excellent analytical, problem-solving, and decision-making skills.
• Exceptional leadership, communication, and interpersonal skills, with the ability to lead and motivate a remote team effectively.
• Proficiency in quality management software and tools.
• Ability to work independently, manage priorities, and meet strict deadlines in a remote setting.
• Experience with biologics or sterile products is a plus.

• Develop, implement, and maintain robust Quality Assurance (QA) systems and procedures in compliance with cGMP, ICH, FDA, and other relevant regulatory guidelines.
• Oversee all QA activities, including batch record review, deviation investigations, CAPA management, change control, and internal/external audits.
• Lead and mentor a team of QA professionals, providing guidance, training, and performance management.
• Ensure that all pharmaceutical products meet established quality standards and regulatory requirements prior to release.
• Manage and conduct internal and external audits, including vendor qualification and audits of contract manufacturing organizations (CMOs).
• Review and approve validation protocols and reports for equipment, processes, and analytical methods.
• Prepare and host regulatory inspections and audits by health authorities.
• Identify potential quality risks and implement proactive measures to mitigate them.
• Contribute to the development and execution of quality strategies and initiatives.
• Stay abreast of evolving regulatory landscapes and industry best practices to ensure ongoing compliance.

• 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/Quality Control.
• Extensive knowledge of cGMP regulations, ICH guidelines, and global pharmaceutical regulatory requirements.
• Proven experience in leading QA teams and managing QA operations in a pharmaceutical manufacturing environment.
• Demonstrated experience with regulatory inspections and successful audit outcomes.
• Strong understanding of pharmaceutical manufacturing processes, product development, and analytical testing.
• Excellent analytical, problem-solving, and decision-making skills.
• Exceptional communication, interpersonal, and leadership skills.
• Ability to effectively manage multiple priorities and meet stringent deadlines.
• Experience with quality risk management principles and tools.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Microbiology, or a related life science field.
• Minimum of 8 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• Extensive knowledge of cGMP regulations, ICH guidelines, and pharmaceutical quality systems.
• Proven experience in managing deviations, CAPAs, change controls, and audits.
• Demonstrated leadership skills with experience managing a team of QA professionals.
• Excellent understanding of pharmaceutical manufacturing processes and analytical testing.
• Strong analytical, problem-solving, and decision-making abilities.
• Exceptional written and verbal communication skills, with the ability to effectively interact with regulatory agencies and senior management.
• Experience with regulatory submissions and inspections is highly desirable.