Key Responsibilities

- Review and approve formulation development protocols, reports and technical documents.

- Review formulation development activities for compliance with GMP, GDP, QMS and applicable regulatory requirements.

- Review and approve BMR/BPR, development batch records and scale-up batch documentation.

- Ensure proper review, completeness and traceability of raw data and laboratory documentation.

- Review process development, optimization and technology-transfer documents from a QA perspective.

- Participate in formulation, analytical and process-development meetings and provide quality/compliance guidance.

- Review equipment qualification, calibration and validation documents related to development activities.

- Handle/review deviations, incidents, OOS/OOT, change controls, CAPA and risk assessments associated with development activities.

- Ensure compliance with Good Documentation Practices (GDP) and data-integrity requirements.

- Review and approve relevant SOPs, protocols, reports and specifications.

- Support scale-up,



exhibit/registration batches and technology-transfer activities.

- Support preparation for internal, customer and regulatory audits/inspections.

- Coordinate with Formulation R&D;, Analytical R&D;, QC, Manufacturing, Regulatory Affairs and Validation teams.

- Maintain appropriate QA oversight of development and stability activities.

Required Knowledge & Skills

- Strong understanding of cGMP, GDP and pharmaceutical QMS.

- Knowledge of ICH Q8, Q9 and Q10 and relevant FDA/EMA requirements.

- Valuable understanding of formulation development and manufacturing processes, particularly OSD and/or injectables.

- Experience with deviation, CAPA, change control, OOS/OOT and risk management.

- Strong documentation-review and data-integrity skills.

- Good understanding of process validation, cleaning validation and equipment qualification.

- Good communication and cross-functional coordination skills.

📌 Urgent Opening For DQA Formulation (Hyderabad)
🏢 MSN Group
📍 Hyderabad