● Approve all master documents like SOP, SMF, VMP, Quality Manuals, Qualification, Validation protocols and reports etc. ● Review and approve QMS documents. ● Qualify and approve the vendor with maintain the audit compliance documents as per cGMP. ● Expert in the field of documentation which includes preparation of formats, procedures, issuance, retention and retrieval of records /documents. ● Review of Specification, STP and AWR of raw materials, packing materials, in process & finished products. ● Experienced in handling deviation, investigation, risk assessment, incident management & trouble shooting during failures. / Review and update the IPQA documents as per guidelines and implement effectively ● Lead and motivate a high-performance team of 22 peoples that delivers high quality work. ● To effectively coordinate with various department for smooth functioning of the plant and Leading team of professionals for achieving organizations goals. ● Problem-solving skills are crucial to analyzing past and current performance and recommending objectives to improve quality product and profitability. ● Handling of new facility project and renovation facility in solid oral doses form as per cGMP. ● Handling training of all departments as per training program and training evaluation, record updating as per schedule. / Handling of Risk analysis of facility, process, equipment’s and system. ● Handling of product quality review (PQR). ● Handling of temperature mapping study of manufacturing, Warehouse facility as per cGMP. ● Handing effectively the internal audits and compliance. ● To handling of VQ (RM & PM). / Handling of quality management system. ● Handling of Equipment, Facility and HVAC Qualification. ● Handling of Cleaning Validation activity. ● Review cGMP, Regulatory guidelines, various Pharmacopoeias and update documents. ● Raw Materials, Packing Materials specification approve in LIMS Software. ● Qualification of Track & Trace System (Sterilizations and Aggregation System for Bulk 2 D Code) As per regulatory regulations.
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