QA Manager _ API _ Global Pharma Company _ Chennai

Job Description

Greetings!!!! We are seeking for a QA Manager role - for Global API Manufacturing company at Chennai. Responsibilities: Responsible for Quality of products manufactured & QMS requirement at manufacturing site • Perform Gap analysis at regular interval to identify any gaps in quality system with respect to change in SOP, updating in pharmacopeia, change in any regulatory guidelines etc, and to inform Head QA to prepare & implement action plan as per guidance of Head QA. • Follow & establishment good documentation and filing system for easy retrieval & maintenance of all quality records Monitor Change control management and review the monthly data on change control status. Review and approval of Change controls, documentation and associated CAPAs and Provide Change control status for site quality management review meeting. • Management of Deviations and CAPA investigations and Periodic review of CAPA status with all concerned for timely closure of the same. • Handling of Out of specification, out of trend results and Customer complaints logging, investigation and Ensure timely closure of CAPA for the same. • Preparation of Annual product reports and Vendor Qualification of Raw Materials & Packing Materials with respect to Vendor Questionnaire Verification, Vendor Audit and Compliance Report Verification prior to Approval. • Review of all validation protocols and reports like process validation, cleaning validation, purified water, WFI validation, & Equipment Qualifications. • Review of online batch records review for all stages of manufacturing & packing activities. • Meeting all the delivery schedules for the products as committed in the Plan. Co-ordination with Research team, Quality Control, Engineering and Warehouse functions to ensure compliance to the committed Plan. • Active participation for timely installation, commissioning and validation of all the equipments and processes in the API Manufacturing facility. • Maintaining and up keeping the area as per the cGMP and Regulatory requirements and putting continuous efforts for improvement in quality and Productivity. • Co-ordination during the execution of Validation batches & process stabilization activities of various APIs & Intermediates. • Co-ordination in Quality Risk Management with various departments and Involving in HAZOP studies of various products to address the EHS issues before to Adopting in plants with safety department. • To ensure implementation and propagation of all EHS norms so as to create safe working Environment.Compliance to 5S and OE documentation. Tamil Speaking is Must Interested candidates kindly share your updated cv to uma@bvrpc.com