Senior Quality Assurance Manager for Pharmaceutical Testing

2 days ago

Kolkata, West Bengal, India QIMA Full time

We are seeking a highly skilled Senior Quality Assurance Manager to lead and manage the Quality Assurance function in our Analytical Testing Laboratory.

The ideal candidate will have extensive experience in handling critical audits, including USFDA, CAPA, GLP, WHO, NABL, and internal audits, and will play a key role in ensuring compliance with pharmaceutical regulatory requirements and industry best practices.

Key Responsibilities:
  • Quality System Management:

- Develop, implement, and maintain the Quality Management System (QMS) to comply with regulatory requirements (USFDA, WHO, NABL, GLP) and industry standards (ISO, ICH).

- Oversee the preparation and management of documentation including standard operating procedures (SOPs), batch records, test methods, and analytical reports to ensure compliance with regulatory standards.

- Implement risk management strategies to identify, assess, and mitigate quality-related risks within the testing laboratory.

  • Audit and Compliance Oversight:

- Lead and manage USFDA, WHO, NABL, GLP, and other regulatory audits, ensuring full preparedness and compliance.

- Coordinate and conduct internal audits to assess the effectiveness of the laboratory's quality system, identifying areas for improvement and ensuring alignment with company policies and regulatory standards.

- Ensure timely and effective resolution of audit findings by developing and executing Corrective and Preventive Actions (CAPA) in accordance with regulatory guidelines and company practices.

- Serve as the primary point of contact during external regulatory audits, inspections, and accreditation assessments.

- Collaborate with regulatory bodies and external stakeholders to ensure continuous improvement in quality and compliance.

  • CAPA Management:

- Lead the CAPA (Corrective and Preventive Action) process, ensuring thorough investigation and documentation of non-conformances, root cause analysis, and implementation of effective corrective and preventive actions.

- Track CAPA effectiveness and ensure corrective actions are sustainably integrated into the laboratory processes to prevent recurrence of issues.

  • Team Leadership & Training:

- Supervise, mentor, and train laboratory personnel on quality standards, testing protocols, regulatory compliance, and internal procedures.

- Conduct regular training sessions to ensure team competency in GMP, GLP, and audit readiness.

- Promote a culture of continuous quality improvement across the lab, encouraging proactive problem-solving and adherence to quality systems.

  • Regulatory Reporting & Documentation:

- Ensure accurate and timely reporting of analytical results, audit outcomes, CAPA documentation, and other quality metrics.

- Ensure all records are properly maintained to meet regulatory requirements, internal standards, and audit readiness.

- Prepare quality reports and metrics for senior management and regulatory submissions.

  • Testing Oversight & Review:

- Oversee the review and approval of analytical test results, ensuring compliance with specifications, regulatory guidelines, and SOPs.

- Investigate any discrepancies or out-of-specification (OOS) results and drive the resolution through root cause analysis and corrective actions.

  • Continuous Improvement & Risk Management:

- Identify and implement improvements to quality management processes, ensuring efficiency, compliance, and reliability of testing systems.

- Monitor emerging industry trends, regulations, and best practices, ensuring the laboratory's practices remain at the forefront of industry standards.

Qualifications:

  • - Education: Bachelor's or Master's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related field. Certifications in Quality Management (e.g., Six Sigma, ISO 9001, or equivalent) or regulatory affairs are a plus.

Experience:

  • - Minimum of 15 years of experience in a Quality Management role within a pharmaceutical testing laboratory.
  • - Proven experience in managing and handling audits such as USFDA, WHO, NABL, GLP, CAPA, and internal audits.
  • - In-depth knowledge of regulatory standards and guidelines including GMP, GLP, FDA, EMA, and ICH.
  • - Experience leading CAPA investigations, root cause analysis, and implementing corrective/preventive measures.

Skills:

  • - Strong leadership skills with the ability to mentor and lead teams to achieve compliance and quality objectives.
  • - Excellent communication and interpersonal skills to interact effectively with regulatory authorities, senior management, and cross-functional teams.
  • - Detail-oriented with strong problem-solving skills and the ability to assess and mitigate risks effectively.
  • - Familiarity with laboratory instrumentation, analytical techniques, and pharmaceutical testing standards.
  • - Proficient in audit preparation, documentation review, and regulatory reporting.

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