Senior Executive - In Process Quality Assurance (IPQA)

As a leading IPQA (In Process Quality Assurance) Team, your role will involve assigning tasks to IPQA chemists for day-to-day activities. You will participate in, review, and approve protocols and reports for various studies such as user requirement specifications, qualifications, validations, risk assessments, and other site-related activities. It is crucial to ensure that all commitments to regulatory authorities are fulfilled for the concerned batch and to actively contribute to the design, development, approval, and implementation of quality systems at the manufacturing site. Your responsibilities will include participating in external inspections of the manufacturing site, preparing CAPA plans for observations, and monitoring their implementation. You will be responsible for reviewing Out-Of-Specification (OOS) and Out Of Trend (OOT) investigation reports, as well as participating in various investigations such as complaints, deviations, change controls, non-conformances, incidences, returned goods, product recalls, vendor audits, and external testing laboratories audits. Your role will also involve participating in self-inspections, reviewing training manuals, providing training on cGMP and quality systems, and overseeing Product Quality Review (PQR) processes. Additionally, you will be responsible for maintaining and implementing quality systems, procedures, validation master plans, site master files, quality manuals, and other relevant documents. Preparation of Monthly MIS reports, looking for continuous improvement opportunities, approving documents in QUANTUM software, overseeing regulatory requirements, releasing or rejecting finished products, ensuring control and stability samples, reviewing SOPs, performing vendor audits, coordinating with formulation and development departments, overseeing analytical method validation, and delegating additional responsibilities as authorized by the Manager-QA. Qualifications Required: - B.Pharm/ M.Pharm degree - Minimum 5-8 years of relevant experience in the IPQA department Note: The company's additional details were not provided in the job description.,