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DGM QAQC

Aarti Pharmalabs Ltd. (APL)

8 - 12 years

0 Lacs

maharashtra tarapur

Posted:2 days ago| Platform: Shine logo

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Skills Required

quality assurance qms regulatory audit cleaning validation analytical method validation vendor audit training lims bpr dms gmp compliance handling customer audits oos investigation risk assessments preparation of site master file electronic system chromeleon software apqr process verification report

Work Mode

On-site

Job Type

Full Time

Job Description

As a Quality Assurance Manager, your role involves ensuring quality standards for all products and manufacturing activities. Your key responsibilities will include: - Ensuring GMP compliance throughout the facility - Organizing, educating, and executing activities as per Quality Assurance objectives - Handling customer audits - Releasing or rejecting APIs and Intermediates - Ensuring workforce motivation and alignment with Company objectives - Handling OOS investigation - Ensuring compliance of QMS/GMP/GLP - Managing Regulatory audits and compliance (USFDA/EU/TGA/WHO/Cofepress/KFDA) - Knowledge and handling of Risk assessments, cleaning validation, Preparation of site master file, Quality Manual, handling of Data integrity - Qualification in electronic systems/software used in QC and instruments/equipment - Handling recalls - Reporting compliance of various audits by outside agencies and customers - Vendor Audit and approval - Good knowledge of Analytical Method Validation and Verification - Review of APQR and Process verification report - Providing training to all employees as per CGMP standards Candidates with experience in the CDMO industry would be preferred.,

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DGM QAQC