Manager-Quality Control

4 months ago

Mumbai, India Abbott Full time

To follow current GMP, safety and GLP norms in the laboratory testing areas, respectively. Awareness on current guidelines, policies, procedures, and techniques of quality control. Upkeep of laboratory with respect to compliance and safety. To maintain cleanliness and its record in the laboratory. Ensure appropriate work allocation to the team members in QC and ensure optimum utilization of resources. To review and approve specifications, standard operating procedures, trends, Technical Reports and Deviation Reports as per requirement. To review and approve Packing materials, Raw materials, Intermediate products, finished products, stability samples, consumable and inward water sample reports. Review and approval of documents of QC. To ensure GxP Compliances. Responsible for ensuring appropriate training to all the subordinates and enhancement of analytical skills and competency. To investigate the out of specification, deviations and laboratory errors in an effective and timely manner and recommend corrective and preventive action and for the same. Review and implementation of compendial changes. Handling, operations, and maintenance of all computerized system software associated with the instruments and documentation. Responsible for receipt and inward of incoming materials in QC laboratory. Responsible of handling alternate vendor development samples of Raw material. Ensure the control and maintenance f documents including the quality system as per the requirements of regulatory authorities which involves all raw data, SOPs and documentation exhibits, protocol, training charts etc. Planning and organizing the audit of the quality system and initiation as well as follow up action of the corrective actions, if any. Investigation of technical complaints. Taking final responsibilities for recommending any regulatory action in the event of noncompliance of tested samples. To ensure planning and utilization of QC budget. SME Network: Play significant role in the EPD stability SME network teams to deliver their respective objectives. Participation as an Auditor in internal audit. To deliver the training site on GMP topics, SOPs, and other technical topics. Providing usage decision of RM, PM, FP tested samples. Any other work assigned by Head Quality.

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