Quality Assurance Operations Supervisor Piramal Pharma Ltd

10.0 - 12.0 years

0 Lacs

mumbai, maharashtra, india

On-site

Be the First to Apply Job Description Essential Duties and Responsibilities Coordinates batch documentation review with operations groups to ensure GMP compliance and timely delivery of products to customers Ensures all documentation and API/drug product batches produced meet the requirements of GMPs and other regulatory health authority requirements Supervises day-to-day functions of the QA Operations team Mentors/coaches and provides succession planning for direct reports Ensures all production and QC documentation has been reviewed prior to disposition If any errors or data integrity issues occur during the manufacturing, packaging, labelling, and testing of API/drug product, that they have been investigated according to internal procedures Ensures QC data meets specifications and any OOS results are investigated per internal procedures Provides QA presence on API/drug product filling/packaging line through documented walkthroughs to ensure GMP compliance Works with global partners in EU/UK QA to ensure batches are released and records provided in a timely manner Manages drug product complaint program ensuring samples are received in a timely fashion and investigations meet established internal procedural requirements and reports back to customer service team through approved software programs Prepare metrics for weekly, monthly and quarterly Management meetings Any other duties as assigned Qualifications Key Competencies (knowledge, skills, and abilities every person must possess to be successful), i.e. Critical Thinking skills using Risk Based logic and reasoning to identify the strengths and weaknesses in QMS, recommend and institute solutions, conclusions, and approaches to problems Demonstrated ability to evaluate quality matters by leveraging GMP experience, analyzing data, while using FDA Risk Based type approaches Attention to detail/ sense of urgency- ability to act quickly and escalate issues Excellent customer service skills and professional demeanor always to interface effectively with all internal and external customers Excellent verbal and written communication skills Energetic, enthusiastic, and motivational disposition Education/Experience BS preferred or combination of education and relevant experience 10+ years experience in Pharmaceutical/Biotech industry Experience in TrackWise, EDMS, LMS or other such software tools for managing the QMS Working knowledge of 21 CFR part 210/211, and part 11, FDA guidance. Knowledge of 21 CFR part 820 Medical Device Regulations preferred. Job Info Job Identification 9341 Job Category Quality Assurance Posting Date 08/22/2025, 10:09 AM Degree Level Bachelor&aposs Degree Job Schedule Full time Locations 3950 Schelden Circle, Bethlehem, PA, 18017, US Show more Show less

Posted 3 weeks ago

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