QC Manager - Pharmaceuticals

Role & responsibilities

• Responsible for QC department and all related activities.
• Ensuring that all necessary testing is carried out and the associated records evaluated
• To check and approved the COA, STP, SOP and other master documents
• Approve specifications, sampling instructions, test methods and other Quality Control procedures
• Ensuring the qualification and maintenance of his department, premises and equipment
• Ensuring that the appropriate validations are done
• Responsible for SOPs, change controls, deviations and CAPAs related to QC
• Participate in internal and regulatory agency audits
• Conduct briefings and technical meetings for top management and representatives of process performance, product quality and of the quality management system and advocating continual improvement
• To ensure current good laboratory compliances and ensuring all SOPs related to quality control laboratory are prepared and reviewed / implemented properly
• To manage an accurate, reliable, efficient and timely testing function of finished products, in-process / validation samples, stability samples
• To manage an accurate, reliable, efficient and timely testing function of raw materials / packaging material and release / rejection of the raw material and packaging material
• To ensure timely release of Finished Product in order to avoid delay in delivery of goods
• To carry out review and suggest periodic training, wherever required
• To investigate and file change control, deviation, out of Specification (OOS), out of trend (OOT) report and Laboratory events whenever observed
• To review the Finished Product Specification/STP and to update them from time to time if required
• To communicate the regulatory, technical and quality information to all the concerned
• To ensure the training about the changes in the standard operating procedure (SOP) if required
• To ensure accurate document preparation / review procedures being carried out relating to API plant samples, finished product, in-process / validation products, stability samples, raw material as per the regulatory norms, checking / monitoring them and issue of certificate of analysis to various departments
• To monitor the activities for stability study protocol / reports to provide the support to regulatory for stability data and document submission
• To ensure proper functioning of all instruments / reducing instrument idle time / preventive maintenance, annual maintenance / calibration of instruments (In-house) or (outside) and monitoring from time to time
• To review and update the specifications as per pharmacopoeia and other regulatory requirements
• To handle the product complaint and respond to it, on receipt of the complaint

Preferred candidate profile

* Currently working as QC - Manager in a reputed Pharmaceutical Formulation rganisation

Has a comprehensive experience in:

1) Testing of raw materials and finished product

2) Create and maintain accurate lab record & documentation

3) Perform routine maintenance and calibration of laboratory instrumentation.

4) Perform analytical analysis using HPLC, GC, UV/VIS and FTIR.

• Documentation Knowledge as per Good Laboratory Practices.
• Create and maintain accurate lab record & documentation
• Exposure of handling HPLC, GC, FTIR, UV Visual instruments.
• Analysis of Raw/Packing/Finished product as per Pharmacopoeia using HPLC, GC, UV/VIS and FTIR.
• Analysis of Semi-Finished product as per Pharmacopoeia.
• Exposure of QC Instruments calibration & qualification.
• Analysis of Process Validation Samples and Stability Samples.
• Perform routine maintenance and calibration of laboratory instrumentation.

Perks and benefits