Senior Executive Quality Assurance
Memphis Vision Care Pvt. Ltd.
Location
Gandhinagar | India
Job description
Experience
Minimum 3-4 years experience in Pharmaceutical Company.
Responsibilities
- To Prepare, reviewing and approving the SOP pertaining to QA department
- Reviewing of all standard operating procedures, test methods, specifications, validation protocols and reports
- Preparation of standard operating procedures, master formula records and final batch processing records
- All the design qualification, installation qualification, operational qualification and performance qualification protocols shall be prepared with the help of other validation team member of user department
- To prepare compliance report of internal audit.
- Review the batch production records , Batch manufacturing record and analytical records to ensure compliance with established procedures
- Ensure that the system laid down for documentation and its control is followed
- Prepare the site master file for the manufacturing site as per regulatory guidelines
- Prepare validation master plan which shall cover all the validation activities with reference to equipments, process, systems and cleaning
- Preparation of stability protocols and review the stability of products
- Preparation of cleaning validation protocol and compilation of cleaning validation report
- Impart the cGMP training to all the personnel training.
- Arrange the retain sample and take entry of retain sample.
- Manage logbooks of QMS(CCN,CAPA, deviation, market compliant)
- Retrieved documents from all departments.
- Prepared documents for regulatory requirement.
- Controlling access to documents.
- To monitor IPQA activity during various processing stages of product like Sampling, Dispensing, Manufacturing, Filling, Filtration, Sterilization, Visual inspection, Labeling and Blister packing, carton coding, Secondary Packaging and dispatch etc.
- To issue, Review of Batch processing documentation.
- To ensure that all the production process are done as per the SOP.
- To review all the production on line documents as per the SOP
- To review the BMR, BPR and QC records. In case of any Deviations/OOS immediately informed to Head QA.
- Record the temperature and Humidity of stability chamber and retain sample room.
- Collect the retain sample during final packing
- To review all department logbooks and filled format for its correctness
- Verified all the record and logbooks of warehouse and GMP related activities.
- To participate in validation study and documentation as per approved protocol
- Any other responsibility assigned by HOD.
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