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Quality Assurance manager for Pharmaceuticals formulation plant ( Tablets and capsules)
To maintain and control an overall quality management system documentation.
Responsible for the preparation planning, coordination and execution of QA training programme.
Assessment of other departments training
Issuance of batch number, batch manufacturing record, Register, SOP's, format, protocols, Analytical protocols to departments
To review the Analytical records, Batch manufacturing record and batch packing record
Preparation of QA-SOP's, Validation protocol aPQR, summary reports based on the Analytical results and Batch documents data.
To coordinate for the validation activities with other department for successful completion
Submit customer questionnaire along with declarations, management of free samples.
Maintaining vendor approval process
Daily assessment of site to ensure GMP compliance level of site through round.
Management of regulatory and customer audit at site
Management of Deviation, Incident. Change control, OOS, Recall, Market complaint, Investigation, CAPA, Risk assessment etc
Interpretation of sales order and overall management of dispatch
Reviewing stability data and sharing inference with management.
Providing data to Regulatory patent or any other authorities
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