QA MANAGER ( PHARMA)

Quality Manager

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.

How to Apply

updated resume

talentacquisition@efrac.org

Contact:

mention “Application for QA Manager – Pharma Testing Laboratory”

Kindly include the following details along with your resume:

• Total Experience:

• Current CTC:

• Expected CTC:

• Notice Period: