Job Description:

- Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and clients’ standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.

- Develop and maintain a Quality Management System in accordance with domestic and international medical device regulatory requirements (FDA, ISO13485, MDD, Health Canada, etc.)

- Manage Quality Control related activities regarding all in-process checks, deviations, RM release, and finished product release. Ensure that products conform to specifications and regulatory requirements.

- Approve or reject all formulations, procedures, specifications, test methods, raw materials, packaging materials, and finished products, including products manufactured at foreign sites, based on conformance / non-conformance to respective specifications that affect the purity, quality, and composition of each product.

- Oversee complaint handling, corrective and preventive actions, internal audit program, supplier quality assurance, product inspection and release, equipment calibration, and control of nonconforming material.

- Maintain and improve product quality by completing product and company system, compliance,



and surveillance audits; investigating customer complaints; collaborating with other members of management to develop a new product, and manufacturing and training methods.

- Prepare quality documentation and reports by collecting, analyzing, and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.

- Approve Raw Material Specifications before purchase. Develop Finished Product Specifications for existing & Recent Products.

- Prepare a Certificate of Analysis for all clients, prepare Stability reports and Nutritional Facts for products.

- Maintain Master formulations, Change Control, and history records. Develop & make a master formula for all new registrations. Identify and analyze issues related to in-process manufacturing and resolve them.

- Review & maintain Work Orders and all related documents. Complaint handling: record all details about the complaint and prepare a complete investigation report, corresponding to the client till it’s resolved.

- Communicating with clients and Laboratory for technical matters. Ensure that the contract laboratories are capable of performing all of the tasks and responsibilities assigned to them.

- Review and verify test protocols, COA’s received from the third-party laboratory. Investigate OOS results received from the laboratory and find solutions.

📌 Manager / Senior Manager - Quality (QA & QC) (Bharuch)
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📍 Bharuch