Quality Control Executive

2 days ago

Kolkata, India Eskag Pharma Pvt Ltd Full time

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 & New 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.

**Job Types**: Full-time, Regular / Permanent

**Salary**: ₹20,000.00 - ₹30,000.00 per month

**Benefits**:

- Provident Fund

Schedule:

- Day shift

**Experience**:

- total work (required)

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