Job Description: Role: Senior Executive - Quality Assurance Reporting: Manager (Quality Assurance) Location: Hyderabad Experience: 7 to 10 years of progressive experience in quality assurance within the formulation (drug product) development, with a focus on R&D operations Qualification: M. Pharma/M.Sc. (Chemistry) from a reputed university. Job Description: Carry out & ensure review of analytical method development, validation, and transfer according to the ICH Q2 and Q14. Carry out & ensure review and approval of quality control activities at analytical development lab and subcontracted facilities. Ensure compliance in Analytical lab and maintained as per Global Requirement. Carry out & ensure tracking and maintaining the documents in Analytical as per requirement of Regulatory. Support participation in the local Manufacturing Review Board (MRB), provide quality input on IMP and manufacturing processes during development. Ensure Management of master and executed manufacturing and analytical record at development site. Ensure Effective implementation of Quality Management System at Development Labs. Ensure Quality operation as per GMP requirement in development site and subcontracted facility. Carry out Handle change control, deviations, Incidents and CAPA management. Carry out & ensure Controlling of documents used in development labs. Support Implement and train global and local QA SOPs in cooperation with GQA Development and local departments. Carry Out review Local SOPs, Technical Agreements, and other quality related documents. Support Global Pharmaceutical SOP team and provide input on corporate procedures. Support Participate on audit of service providers (CMO/CRO) along with lead auditor. Ensure departmental activity for smooth and effective functioning as per the written procedure. Carry Out Complete review of documents generated to support regulatory submissions. Preferred Competencies in the role . Working experience with diverse dosage form and differentiated products preferred. Timely achievement of the project deliverables In-depth knowledge of GMP, GLP, and regulatory requirements for pharmaceutical development. Experience with quality systems such as document management, deviation management, change control, and CAPA. Excellent communication skills (written and verbal) and interpersonal skills, with the ability to collaborate and influence cross-functional teams. Strong analytical skills, attention to detail, and the ability to identify and mitigate risks effectively. Critical thinking, troubleshooting and problem-solving skills. Engagement & accountability towards the defined purpose Good team player Location: Ferring India FHPDC R&D
