Chemist / Officer / Executive / Assistant Manager - Quality Assurance

Job Description:

• Key Responsibilities:

  • Documentation Management:

    • Review, approve, and control various quality documents, including Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), Specifications, Test Procedures (STPs), and other quality-related documentation.

    • Ensure proper archiving, retrieval, and revision control of all controlled documents.

    • Participate in the preparation and review of site master files (SMF), validation master plans (VMP), and annual product quality reviews (APQR).

  • In-Process Quality Assurance (IPQA):

    • Conduct regular in-process checks and online monitoring of manufacturing operations to ensure adherence to BMRs, SOPs, and cGMP guidelines.

    • Perform line clearances before starting new batches and product changeovers.

    • Verify dispensing of raw materials and ensure proper handling and storage of materials throughout the production process.

    • Monitor environmental conditions (temperature, humidity, etc.) in manufacturing and storage areas.

    • Collect and control in-process, intermediate, semi-finished, and finished product samples.

  • Batch Release Activities:

    • Review executed BMRs, BPRs, analytical records, and other relevant documentation for completeness, accuracy, and compliance with specifications and cGMP.

    • Ensure all deviations, incidents, OOS/OOT results, and change controls related to a batch are properly investigated, documented, and closed before batch release.

    • Prepare and/or review batch release documentation for final product disposition.

  • Quality Management Systems (QMS):

    • Actively participate in the implementation and maintenance of the Quality Management System (QMS).

    • Initiate, investigate, and close deviations, incidents, Out-of-Specification (OOS), and Out-of-Trend (OOT) results, ensuring root cause analysis and effective CAPA (Corrective and Preventive Actions) implementation.

    • Review and approve change control requests, ensuring proper assessment of impact on product quality and regulatory compliance.

    • Handle and investigate market complaints, product recalls, and customer feedback, ensuring timely resolution and corrective actions.

  • Audits and Inspections:

    • Support internal audits to assess compliance with quality standards and identify areas for improvement.

    • Assist in preparing for and hosting external regulatory inspections (e.g., USFDA, EDQM, WHO) and customer audits.

    • Help in developing and implementing corrective actions in response to audit observations.

  • Validation & Qualification:

    • Participate in the review and approval of validation protocols and reports (process validation, cleaning validation, analytical method validation).

    • Support the qualification and calibration of manufacturing equipment, analytical instruments, and utility systems.

  • Training & Compliance:

    • Provide training to manufacturing and other relevant personnel on cGMP principles, SOPs, and quality-related procedures.

    • Foster a strong quality culture within the organization.

    • Stay updated with the latest regulatory requirements and industry best practices in API manufacturing.

  • Supplier & Vendor Management (as applicable):

    • Assist in the qualification and re-qualification of raw material suppliers and contract manufacturers.

    • Review supplier quality documentation and provide input on supplier performance.