QA Associate - Reviewer 2nd shift

Responsibilities

• Review batch production records (BPRs), including associated documents (e.g., manufacturing instructions, protocols, and equipment logs), to ensure they are complete, accurate, and compliant with GMP and regulatory guidelines.
• Verify that all entries are properly documented, signed, and dated by the relevant personnel, and ensure that any discrepancies are resolved before approval.
• Ensure batch records and associated documentation meet regulatory requirements from agencies such as the FDA, EMA, and other relevant authorities.
• Review, creation and revision of BPRs, SOPs, and other documents related to manufacturing processes.
• Ensure batch records are audit-ready and fully compliant for both internal and external audits (e.g., FDA, GMP inspections).
• Assist audit teams by providing required batch documentation and responding to audit queries related to manufacturing processes and batch records.
• Recommend process improvements to enhance the batch review process, reduce review time, and ensure better compliance.
• Address any issues or concerns related to batch records raised by cross-functional teams and ensure timely resolution.
• Ensure completion of individual training assigned and follow company policies, safety requirements, cGMP and SOP's.
• Review of engineering records (temperature and humidity data, calibration reports and PMP records).
• To take daily Quality rounds at shop floor to ensure shop floor is maintained in state of compliance and per GMP requirement.
• Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during batch manufacturing and packing.
• Other duties [additional support] that management may assign from time to time.

Skills

• Familiarity with document management systems (e.g., Master Control).
• Ability to analyze and resolve batch documentation issues in a timely and efficient manner.
• Experience in preparing for regulatory inspections and audits.
• Excellent organization skills with the ability to focus on details.
• Strong organizational and time-management skills to handle multiple batch reviews simultaneously.

Educational Qualification

Bachelor's degree in pharmacy, Life Sciences, Chemistry, or a related field.

Work Experience

• Minimum 2-3 years of experience in batch record review or quality assurance in the pharmaceutical industry.
• Strong knowledge of GMP, regulatory requirements (FDA, EMA), and pharmaceutical manufacturing processes.
• High attention to detail and accuracy in reviewing complex documentation.
• Strong communication skills and the ability to collaborate effectively across departments.