Executive / Senior Executive - Development Quality Assurance (Pharma Business)
Job Description
Ensure Quality Assurance oversight for new product development, reformulation, technology transfer, scale-up, exhibit, and validation batches.
Review and approve development-related documents including SOPs, specifications, protocols, analytical methods, batch records, validation reports, stability protocols, and reports.
Coordinate and monitor Change Controls, Deviations, Incidents, CAPA, Risk Assessments, and Investigation activities related to product development.
Perform in-process quality monitoring and compliance checks during formulation development, pilot trials, exhibit batches, and technology transfer activities.
Review and evaluate analytical testing data, stability study results, method validation/verification reports, and development reports to ensure compliance with quality requirements.
Coordinate new product quality testing activities with R&D, Quality Control, Production, and Regulatory Affairs to support timely product development and submission.
Ensure compliance with cGMP, GLP, Data Integrity, WHO, USFDA, PIC/S, ICH, DGDA, and other applicable regulatory requirements throughout the product development lifecycle.
Conduct internal audits, compliance reviews, and quality risk assessments within Development and R&D functions and ensure timely closure of observations.
Maintain effective document control and ensure proper archival, issuance, and retention of development and quality records.
Support regulatory inspections, customer audits, dossier preparation, product registration activities, and successful commercialization of new products.
Experience
- At most 3 years
- The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
- Freshers are also encouraged to apply.
Education
- Master of Pharmacy (M.Pharm)
Additional Requirements
- Age At least 22 years
Experience in Development QA, R&D QA, QA, QC, or Product Development of any pharmaceutical company.