Opening in Formulation DQA at MSN Group | B.Pharm, M.Pharm Apply

MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible.

Formulation DQA

Job description
• Review and approve development protocols, reports, and technical documents for formulation, analytical, and process development.
• Ensure development studies are conducted as per Good Documentation Practices (GDP) and QMS procedures.
• Oversee batch manufacturing records (BMR/BPR) and analytical data for R&D and scale-up batches.
• Participate in formulation and analytical strategy meetings to ensure quality alignment.
• Development SOPs and related quality documents.
• Master formula records and batch manufacturing records.
• Analytical method validation and verification protocols.
• Evaluate and assess changes raised during development (e.g., formulation, process, analytical method, equipment).
• Review deviations, OOS/OOT investigations, and ensure timely closure with robust root cause analysis (RCA) and CAPA implementation.

• Support trending and effectiveness checks for CAPAs related to development operations.
• Review TT protocols and reports for process and analytical method transfer.
• Ensure data integrity and traceability of transferred methods and processes.
• Coordinate with receiving site QA/QC for TT documentation and verification.
• Participate in pre-approval audits / readiness checks for technology transfer batches.
• Support quality evaluations and audits of CMOs, CROs, and material vendors.
• Review quality agreements and ensure quality compliance for outsourced activities.
• Provide DQA inputs for CMO qualification and ongoing quality monitoring.
• Ensure adherence to data integrity (ALCOA+) principles in all development documentation.
• Conduct internal audits / self-inspections of development labs for compliance verification.
• Provide training to R&D and analytical staff on QMS and documentation practices.
• Support QA inputs for CMC documentation in regulatory submissions (IND, NDA, ANDA, IMPD).
• Ensure that QMS elements (Change Control, Deviation, OOS, CAPA) are effectively applied in the development area.
• Support quality risk assessments (QRA) and QbD initiatives during formulation design.
• Identify process or system gaps in development operations and initiate improvement projects.
• Participate in cross-functional quality initiatives (e.g., method lifecycle management, data integrity strengthening).
• Support knowledge management and lessons learned documentation after development projects.

Candidate Profile
Experience : 5 to 10 years in QA.
Qualification : M.Pharm or B.Pharm

Preferred Skills
• Knowledge of ICH, FDA, EMA, WHO, and ISO guidelines
• Exposure to QbD, risk management, and data integrity systems
• Good communication and writing skills

Additional Information
Experience : 5 to 10 years
Qualification : M.Pharm or B.Pharm
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 20th December 2025