Assistant Manager - QC

Role & responsibilities

• To ensure implementing agreed quality norms of raw materials and finished goods of the respective Areas of production. 
• To ensure planning and developing quality norms of raw materials and finished goods as per the overall Mfg plan of the unit. 
• To establish system to release the materials as per the timelines provided by ensuring the compliance of the laboratory to meet regulatory bodies.
• To establish the system and process for releasing or rejecting all finished products. 
• Establishing a system to release or reject raw materials, intermediates, packaging, and labeling materials
• Reviewing completed batch production and laboratory control records of critical process steps before release of the finished product for distribution 
• Approving all specifications and master production instructions
• Approving all procedures affecting the quality of intermediates or Finished products
• Yearly vendor evaluation of RM / PM
• To maintain Good Laboratory Practices in Quality control laboratory area and ensure the relevant compliance as per FAMI- QS, IMS, cGMP, and other regulatory requirements.
• Approving changes that potentially affect intermediate or Finished products quality
• Reviewing and approving validation protocols and reports.
• To ensure Quality-related complaints are investigated and resolved.
• To ensure that effective systems are used for maintaining and calibrating critical equipment
• Strong documentation of stability records to support retest or expiry dates.
• To ensure proper storage conditions quality checks for finished products and/or intermediates.
• Adequate laboratory facilities for testing & approval and modernize Laboratory Instrumentation testing facilities..
• Work allotment on daily basis to all chemists as per planning received according to dispatches.
• Record of all no-conformance/OOS, deviations with a time bound CAPA. Reviewing of all analytical raw data, COA and other testing related protocols and reports online prior to release.
• Online rejection of all incoming RM/Solvents after investigation and close with a time bound CAPA incase of laboratory error.
• Reviewing and updating in specification/STPs, SCP in due date of revision or as per need base.
• Rejection of finished product after investigation and identify laboratory error.
• Reviewing of instruments calibration in their due date and maintain breakdown history.
• Maintaining a calibration calendar of all lab equipments and timely addition or deletion in case of any new instrument installed.
• To prepare departmental budget, review expenditure and ensure that expenses is within target.
• Training of QC executives periodically assessed along with new regulatory requirements.
• Training and development of team members.
• To ensure implementation of  ISO 9000, ISO-14000, OHSAS -18000, TPM  and WCM .
• To ensure implementation of 5S in lab and office.
• Responsible for adherence to EHS policy .