:

• To review the maintenance of analytical instruments, facilities, records, and documents.

- To review validation activities, including analytical test procedures, instruments, and calibration of control equipment.
- To ensure that initial and ongoing training of Quality Control personnel is conducted as per requirements.
- To update final product specifications in line with statutory requirements.
- To review documentation related to retained samples and periodic observations.
- To analyze and approve finished products, including issuance of Certificates of

Analysis (CoA).

- To review electronic data and metadata of instrumental analysis, as required.
- To ensure and review audit trails of GC/HPLC systems.
- To review audit trails in electronic systems.
- To review analytical data/results provided by external laboratories.
- To verify raw data of instruments against soft copies before release of finished products.
- To review microbiological analytical reports, raw data sheets, and inward registers of finished products.
- To oversee recent equipment qualification and review DQ/IQ/OQ/PQ documentation.
- To participate in internal and external audits and ensure effective implementation of

CAPA.





- To carry out development and validation of new drug substances and drug products.
- To handle incidents, change control, deviations, and OOS/OOT cases.
- To ensure compliance with the Quality Management System (QMS) in line with regulatory and customer expectations.
- To release or reject batches of finished products.
- To review batch records and laboratory control records of critical process steps prior to API release for distribution.
- To ensure that critical deviations are properly investigated and resolved.
- To approve specifications and master production instructions.
- To ensure execution of internal audits (self-inspections) and compliance thereof.
- To review and approve validation and qualification protocols and reports.
- To ensure investigation and resolution of quality-related complaints.
- To ensure effective systems for maintenance and calibration of critical equipment.
- To review and update quality documents as per schedule or as required.
- To investigate product failures, OOS, OOT, and customer complaints.
- To assign responsibilities to QC team members (Assistant Manager, Senior Executive,

Executive, Officer, Jr. Officer, Associate) based on experience and expertise.

📌 Manager Quality Control (Vadodara)
🏢 Acumen360 Consulting u0026 HR Solutions
📍 Vadodara