:

• 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 current 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