:

- Key Responsibilities:
- Documentation Management:
- Review, approve, and control various quality documents, including Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), Specifications, Test Procedures (STPs), and other quality-related documentation.

- Ensure proper archiving, retrieval, and revision control of all controlled documents.

- Participate in the preparation and review of site master files (SMF), validation master plans (VMP), and annual product quality reviews (APQR).

- In-Process Quality Assurance (IPQA):
- Conduct regular in-process checks and online monitoring of manufacturing operations to ensure adherence to BMRs, SOPs, and cGMP guidelines.

- Perform line clearances before starting new batches and product changeovers.

- Verify dispensing of raw materials and ensure proper handling and storage of materials throughout the production process.

- Monitor environmental conditions (temperature, humidity, etc.) in manufacturing and storage areas.

- Collect and control in-process, intermediate, semi-finished, and finished product samples.

- Batch Release Activities:

- Review executed BMRs, BPRs, analytical records, and other relevant documentation for completeness, accuracy, and compliance with specifications and cGMP.

- Ensure all deviations, incidents, OOS/OOT results, and change controls related to a batch are properly investigated, documented, and closed before batch release.

- Prepare and/or review batch release documentation for final product disposition.

- Quality Management Systems (QMS):

- Actively participate in the implementation and maintenance of the Quality Management System (QMS).

- Initiate,



investigate, and close deviations, incidents, Out-of-Specification (OOS), and Out-of-Trend (OOT) results, ensuring root cause analysis and effective CAPA (Corrective and Preventive Actions) implementation.

- Review and approve change control requests, ensuring proper assessment of impact on product quality and regulatory compliance.

- Handle and investigate market complaints, product recalls, and customer feedback, ensuring timely resolution and corrective actions.

- Audits and Inspections:

- Support internal audits to assess compliance with quality standards and identify areas for improvement.

- Assist in preparing for and hosting external regulatory inspections (e.g., USFDA, EDQM, WHO) and customer audits.

- Help in developing and implementing corrective actions in response to audit observations.

- Validation & Qualification:

- Participate in the review and approval of validation protocols and reports (process validation, cleaning validation, analytical method validation).

- Support the qualification and calibration of manufacturing equipment, analytical instruments, and utility systems.

- Training & Compliance:

- Provide training to manufacturing and other relevant personnel on cGMP principles, SOPs, and quality-related procedures.

- Foster a robust quality culture within the organization.

- Stay updated with the latest regulatory requirements and industry best practices in API manufacturing.

- Supplier & Vendor Management (as applicable):

- Assist in the qualification and re-qualification of raw material suppliers and contract manufacturers.

- Review supplier quality documentation and provide input on supplier performance.

📌 Chemist / Officer / Executive / Assistant Manager - Quality Assurance (Ankleshwar)
🏢 SDP HR Solution
📍 Ankleshwar