Manager Quality Control

Job Description:

• 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 new 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.