5.0 - 9.0 years

0 Lacs

maharashtra

On-site

As an Assistant Manager/Manager- Quality Assurance, your responsibilities will include: - Reviewing and approving Standard Operation Procedures (SOP's) for all departments, ensuring timely completion of reviews and revisions according to the specified revision date. - Evaluating and approving analytical method validation protocols and reports, process method validation protocols and reports, water system validation protocols and reports, as well as equipment/instrument qualification protocols and reports. - Reviewing and approving raw material, packing material, semi-finished product, and final product specifications and test methods for analysis. Approving artwork and shade cards for printed packing material. - Overseeing and approving stability protocols and data. - Coordinating and supporting on-site audits conducted by customers and agencies, and implementing necessary corrective actions based on audit findings. - Developing, preparing, and implementing quality systems across the site. - Providing training to all staff members. - Reviewing and approving deviations, change control, and CAPA processes. - Planning and conducting internal audits for all departments. - Reviewing and approving batch manufacturing and batch packing records. - Ensuring the quality of manufactured products through an in-process quality assurance system. - Reviewing executed batch manufacturing records, batch packing records, finished product test reports with analytical data, and subsequently releasing batches for market distribution. - Ensuring data integrity compliance at the site. - Maintaining and improving product quality by conducting product, company, system, compliance, and surveillance audits, and investigating customer/market complaints. - Preparing FDA licensing documents, QA documents for export orders. - Creating quality documentation and reports by collecting, analyzing, and summarizing information and trends, including failed processes, stability studies, recalls, corrective actions, and re-validations. - Undertaking any additional responsibilities assigned by higher management as needed.,

Posted 2 weeks ago

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