Roop Narayan Email & Phone Number

•. Creation, approval and implementation of quality systems and procedures at site•.. Responsible for review and approval of master documents ( SOPs, Protocols, Batch Records, Specifications, analytical records etc).•. Release or rejection of raw materials, packaging materials, intermediates and finished APIs based on assessment of results against specifications.•. Responsible for selection, up gradation, procurement, installation and qualification of laboratory equipments.•.Participate in investigation and approval of events (deviations), temporary changes non conformance, Out of specification (OOS) results and failures.•. Management of change controls of products, process, test method, equipments and facilities.•. Evaluation and investigation of customer complaints and implementation of corrective and preventive actions; as applicable.•. Participation in the review and revision of QC procedures, standard testing procedures, specifications, method validation and cleaning validation.•.Monitoring of updating standard test procedures as per compendial changes.•. Responsible for the implementation of cGMP and GLP systems.•. Providing inputs and technical guidance on analytical methods.•. Monitoring for self inspections or quality audits for effectiveness and applicability of quality system.•. Monitoring and approval of validation activities such as process validation, cleaning verification and validation and analytical method validations.•. Monitoring and approval of qualification activities of equipment / instruments and computer systems.•. Monitoring and approval of calibration and preventive maintenance program for manufacturing equipment and laboratory equipment and instruments.Management and final closure of internal and external audits.•. To coordinate with various functions such as manufacturing, engineering, R&D, Purchase, Marketing as per requirement..

Listed skills include Gmp, Glp, Validation, Raw Materials, and 12 others.

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  Knipss Sultanpur

  Second