Senior Executive - In Process Quality Assurance (IPQA)

Job Description

To lead IPQA (In process Quality Assurance) Team and its monitoring by assigning tasks for IPQA chemists in day to day activities. Participating, reviewing and approval of protocol and reports of user requirement specifications, qualifications, validations, risk assessment and any other study to be performed at the site. To ensure the commitments (marketing authorization and the manufacturing authorization requirements) given to regulatory authorities for the products have been met for the batch concerned. To participate in designing, developing, approving and implementation of the quality systems at the manufacturing site. Participate in the external inspections of the manufacturing site, prepare Corrective and Preventive Action (CAPA) plan for observations and monitor its implementation. Review of Out-Of-Specification (OOS) and Out Of Trend (OOT) investigation reports. Participate in the investigation of complaint, deviation, change control, non conformance, incidence, returned goods, product recall, vendor audit, external testing laboratories audit; its impact assessments; review its reports and monitor the implementation of Corrective and Preventive Action (CAPA). Participate in self inspection and implementation of its observations. Review of training manual and provide training on cGMP and quality systems Overview of Product Quality Review (PQR) and approval of its reports. To oversee that quality systems, procedures, validation master plan, site master file, quality manual and such documents are maintained in current state and implemented effectively. Preparation of Monthly MIS report including IPQA activities for QA Department. To look for continuous improvement. To approve documents in the QUANTUM software after approval of Head QA or Designee . To oversee the fulfillment of regulatory requirements of RA department. Releasing or rejecting all finished products in absence or direction of Manager QA. Responsible for Ensure the control sample and stability samples of finished product and submission to the QC for analysis Review of Standard Operating Procedures (SOPs) and guidance to the junior in preparation of SOPs. Perform vendor audit for starting material and packaging material vendors; external testing laboratories and other service providers. Coordination with formulation and development department for new product introduction at facility or change in product process or formula. To oversee analytical method validation and verification activity. The additional responsibilities shall be delegated on day to day basis under authorization of Manager-QA. Pedigree B.Pharm/ M.Pharm with minimum 5-8 years of relevant experience in IPQA department