1.0 - 2.0 years

0 - 2 Lacs

Aurangabad

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Quality Assurance Batch Release Organization Context Position Title: QA Batch Release Employee Name: Grade : Department: Location: Aurangabad Reports to: Quality Assurance Head Reported by: Plant Associates Job Objective To assure Quality of products Ontime BMR review and release with 100 % compliance. Primary responsibilities Strategic and planning To ensure the Plant complies to the QMS system as per the laid down guidelines. Functional Core Review of production schedule and their compliance to the specific requirements in the manufacturing of products. Ensure correct and timely issuance of batch documents. Review the completed batch documents and ensure compliance to the manufacturing process before the batch is released. Ensure timely review and release of batch manufacturing record as per GDP. Ensure traceability and reconciliation of All documents and review the same for non-compliance. Ensure proper storage of all the Batch manufacturing record in a systematic manner for easy and quick retrieval. Maintenance and Destruction of documents after its expiry period with proper record as per SOP. Support to QA Manager during the internal and external audits. To perform Usage Decision of batch in absence of QA head. Internal process Adherence to Regulatory Compliance, Compliance to GMP Audit/Process Audit, BMR review and Batch Release to meet regulatory requirements, Ensure c-GMP compliance during the entire manufacturing process. People development Training on compliance to Data Integrity. Training on the requirement of Online documentation. Key Result Areas Strengthening the review mechanism of batch records Effective review of batch records. Timely release batches as per the daily plan Compliance during Internal, external & Regulatory audits Key Interfaces Internal InterfacesExternal Interfaces All plant level functions Sales & CSR Marketing Regulatory dept Central Quality Assurance Vendors, regulatory bodies, customer auditors Competency Technical Competency T CompassLeadership Competency L CompassCompetencyLevelCompetency Level

Posted 2 weeks ago

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Assistant Manager / Deputy Manager - Regulatory Affairs - Mexico Alembic Pharmaceuticals

10 - 16 years

10 - 15 Lacs

Vadodara

Work from Office

Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Assistant Manager/ Deputy Manager based at our Corporate Office - Vadodara, Gujarat. Job Criteria: B.Pharm or M.Pharm qualification having experience between 10 - 15 yrs. with dossier filling experience in MEXICO Countries. Knowledge for review of quality documents like executed batch documents, method validation, change Good communication skill Job Responsibility: Should have through knowledge of Mexico submission. Should have understanding for requirements of Mexico. Should have understanding for review of regulatory documents like batch record, specifications, COAs, stability data, change control, process validation report etc. Should have knowledge of review of method validations, chromatograms, dissolution profile, raw data etc. Interested candidate can share cv on creyesha.macwan@alembic.co.in

Posted 2 months ago

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