Urgent Opening For DQA Formulation

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.
• Strong documentation-review and data-integrity skills.
• Good understanding of process validation, cleaning validation and equipment qualification.
• Good communication and cross-functional coordination skills.