Pharmaceutical Laboratory Director

13 hours ago


Kolkata, West Bengal, India QIMA Full time
About Us

We are QIMA, a leading provider of quality assurance services. Our team is dedicated to helping pharmaceutical companies achieve compliance and quality excellence in their testing laboratories. As a Regulatory Compliance Officer, you will play a critical role in ensuring that our laboratory operations meet the highest standards of quality and regulatory compliance.

Your Key Responsibilities:
  • Develop, implement, and maintain a robust Quality Management System (QMS) that meets regulatory requirements (USFDA, WHO, NABL, GLP) and industry standards (ISO, ICH).
  • Oversee the preparation and management of documentation, including 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.

Qualifications:
  • 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.
  • 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.

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