Job Details

• Capable to lead a team & consistent performer with people management skills
• Successfully leading QC team for regulatory audits like USFDA, EU, ENVISA, TGA etc. in a leading role and should have working experience at managerial cadre of not less than 02-05 years.
• Well versed in handling of QC related OOS,OOT, deviation and incidence investigations, Train Staff, Operators and update their skills (cGMP, Safety, etc.)
• Trouble shooting, Planning, Implementing and prioritizing Quality Control Systems and jobs as per Plant requirements w.r.t. Raw Materials, in process materials and Finished Products in coordination with PDL, R & D, Production, Warehouse, Purchase, RA and QA.
• Documentation and validation of process and analytical methods as per cGMP requirements.
• Responsible for stability management.
• Responsible for Lab commissioning and improvement of laboratory systems.
• Responsible for CAPA management and Change management procedures (Change control).
• Responsible for receiving and conducting Analytical method transfers to other locations.
• Implementation of Pharmacopoeia changes as and when required.
• Conducting periodic audits - QC
• Technical training and evaluation of Quality control personnel, further continuous training for the quality systems improvements & changes and skill level enhancement, Periodic cGMP trainings
• Handling of market complaints in coordination with cross functional departments
• Responsible for Analytical Method Verification
• Responsible for Cost control and Quality improvement initiatives
• Ensuring the safety of laboratory and personnel through best GLP practices

• Good communication skills (both written & verbal) in English
• Planning & prioritizing the daily functional activities
• Good knowledge of SAP, QAMS and other applications with respect to functional requirements
• Multi-tasking ability and time management skills
• Inter & Intra team coordination skills

Reference ID - GH/PHL/JC//13052020//90867/Manager - Quality Control