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.
Good understanding of formulation development and manufacturing processes, particularly OSD and/or injectables.
Experience with deviation, CAPA, change control, OOS/OOT and risk management.
Solid documentation-review and data-integrity skills.
Valuable understanding of process validation, cleaning validation and equipment qualification.
Valuable communication and cross-functional coordination skills.

📌 Urgent Opening For Dqa Formulation Hyderabad
🏢 MSN Group
📍 Hyderabad