Position will be responsible for batch documents audit / review and release of finished products for market as per Abbott policies, SOPs, and Drug Act 1976. Reviewing / approving batch manufacturing / or packaging directions on Darius. Area GEMBA’s for inspection readiness.

Major Responsibilities:

• To make sure that activity does not result in delay or non-availability of product due to delay in batch document audit & release.
• To review and release finished pharmaceutical products for market distribution after a thorough review of all relevant documentation, including batch manufacturing and packaging processes, testing results, and compliance with local regulatory requirements and site SOP, before certifying the batch for release in BPCS.
• To ensure that batches produced are in compliance with Abbott quality standards and regulatory registered specifications.
• To ensure that any changes or deviations in respective batch have been notified in accordance with a defined reporting system before any product is released for market.
• To participate in routine batch release meetings and activities to prioritize batches requiring review for market release based on supply needs.
• Timely and effectively resolve documentation discrepancies and issues with operations and quality personnel in a timely manner to allow for batch release.
• To issue labels through BPCS related to batch processing for different production stages, where required.
• To ensure that any additional sampling (for example, Stability sampling, microbiological sampling etc.) have been carried out in respective batch before market release, as appropriate to cover any changes or deviations.
• To assist and develop, draft and review SOP’s related to QA functions in accordance with cGMP / or as per requirement.
• To conduct periodic trainings of management or non-management staff on Good Documentation Practices to reduce errors in batch documentation and records.
• Train new QA associates on batch record review / audit and release on BPCS.
• To performance necessary transactions in BPCS related to batch disposition i.e., Hold, Release or Reject, as or when required.
• To collect data and share quality metrics with relevant stakeholders related to batch document audit and release activities to proactively identify trends and atypical observations.
• Coordinate with cross-functional team to prepare Annual Product Record Reviews (APQR), discuss trends and atypical observations, and recommend improvement actions, where needed.
• To review batch manufacturing / or packaging directions or other associated documents in case of any changes made before approval on Darius.
• Handling of samples picked by drug Inspector for secure storage as per product storage requirement.
• Contribute to and support continuous improvement initiatives within the QA department.
• Any special project assigned by Manager QA Inspection & Batch Release.
• GEMBA inspection of Warehouse, Utilities and facilities (e.g. required building /environmental / equipment etc.) as per Policies / Procedures, cGMP and Guidelines.
• To assist Manager QA Inspection & Batch Release to collect data and preparing monthly Quality Metrics Report and Quality trend report.
• To assist Manager QA Inspection & Batch Release to collect data and preparation of Management Review.
• Calculation of KPI & discuss the trend with Manager QA Inspection & Batch Release.
• Audit follow-up for corrective action implementation in area of activity.
• To actively participate in handling of low impact exception reports from initiation to close out.
• Update batch related information on DRIS.

Education/Knowledge & Experience:

• Science Graduate/Master’s; preferably Pharm D or M.Sc.
• 2 - 3   years’ experience in relevant field.