Assistant General Manager

Job Description : AGM/DGM-DQA For Reputed Pharma Company Candidates should be Msc/MPharm with 15-20 yrs experience have good understanding of Analytical / Bioanalytical, conjugation and formulations of vaccines/biologics/Biosimilar.Should ensure the departmental activities for smooth and effective functioning as per the written Procedures.Responsible to review the master documents, but not limited to:Analytical method validation protocols and ReportsCleaning validation protocols and reportsHold time study protocols Sampling protocolsSpecifications and STP’sSolubility and Sink Condition protocols and reports.Change controlsJustificationsDeviations and incidents Review of BMR, BPR & MFC reports from the Formulation and Conjugation and analytical Laboratory. Review the Technology transfer documents received from respective departments.Review the Raw Materials, Intermediates & in-process specifications & MOA along with supporting data. Review the Finished and Drug product specification & MOA along with supporting data of the batches.Review and approve the assigned documents in Document Control System.Responsible to ensure the quality operations as per WHO requirements in R&D. Responsible for tracking & maintaining the documents in the AR&D as per requirements.Prepare and impart training of departmental SOPs as per WHO, ICH and cGMP requirements.Responsible to conduct the Internal Audits across all the departments at specified frequency.Responsible to review the analytical raw data for the validation reports.Responsible to review the soft copies of analytical chromatograms in the instruments and ensure the data integrity issues in the AR&D, Conjugation and Formulation R&D.Responsible to maintain the archival of all the GMP documents.Preparation and review of trends (Statistical analysis). COMPETENCIES REQUIREDAnalytical ability Current QMS Vs Required QMS. Ability to develop and implement QMS. Ability to develop SOP’s as per WHO guidelines. Facilitates communication between team members to ensure efforts are aligned.Proven team player skills in building teams. KNOWLEDGE & SKILLSShould be familiar with WHO & ICH guidelines. Should be familiar with overall Vaccine R&D and plant operation.Ability to effectively operate in a fast-moving international business environment.,

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