General Manager Quality Assurance / Skybiotech Life Sciences

5.0 - 10.0 years

0 Lacs

maharashtra

On-site

As a General Manager of Quality Assurance with 5-10 years of experience, your responsibilities will include validations and qualifications, preparation and implementation of the VMP & CMP, process validations, cleaning validation, and facility validation. You will also be in charge of equipment and instrument qualifications including URS, DQ, IQ, OQ, and PQ. Handling of deviations/incidences, internal quality audits, GMP audit system, annual product review, vendor audits, and qualifications are crucial aspects of this role. Your duties will also involve documentation, effective implementation of the document control system, preparation of Standard Operating Procedures (SOP), GMP & GLP records, and approval of Master Formula Records and batch manufacturing records. Quality control and stability studies will be under your supervision, and you should be fully conversant with the latest GLP requirements. Experience in handling sophisticated instruments like HPLC, GC, FTIR independently is required. Moreover, familiarity with ANDA and EU submissions, handling of regulatory deficiencies/queries work, preparation of Drug Master Files & dossiers for export markets are important responsibilities. Your expertise in ensuring compliance with quality standards and regulations will be essential in this role. If you are a detail-oriented professional with a solid background in quality assurance and a proven track record of successfully managing quality control processes and regulatory submissions, we encourage you to apply for this position.,

Posted 6 days ago

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