Urgent Opening For DQA Formulation

MSN Group; Hyderabad; On-site; INR 1,100,000 - 1,600,000; Full time

Job summary

MSN Group in Hyderabad, India seeks a QA/Regulatory professional to review formulation development protocols and ensure GMP/GDP/QMS compliance across development and technology-transfer activities.

The role involves reviewing batch records, data integrity, investigations, deviations, CAPA and audits, coordinating with R&D, QC, Manufacturing and Regulatory Affairs to maintain QA oversight of development and stability activities.

Qualifications

• Strong knowledge of cGMP, GDP and pharmaceutical QMS.
• Familiar with ICH Q8, Q9 and Q10 and FDA/EMA requirements.
• Understanding of formulation development and manufacturing for OSD or injectables.
• Experience with deviation, CAPA, change control, OOS/OOT and risk management.
• Excellent documentation-review and data-integrity skills.

Responsibilities

• Review and approve formulation development protocols, reports and technical documents.
• Ensure GMP, GDP, QMS compliance and regulatory requirements review.
• Review BMR/BPR, development batch records and scale-up batch documentation.
• Ensure completeness and traceability of raw data and lab documentation.
• Review process development, optimization and technology-transfer docs from a QA perspective.
• Participate in formulation, analytical and process-development meetings and provide QA guidance.
• Review equipment qualification, calibration and validation documents connected to development.
• Handle deviations, incidents, OOS/OOT, change controls, CAPA and risk assessments.
• Ensure GDP data integrity and GDP compliance.
• Review SOPs, protocols, reports and specifications.
• Support scale-up, exhibit/registration batches and technology-transfer activities.
• Assist preparation for audits/inspections.
• Coordinate with Formulation R&D, Analytical R&D, QC, Manufacturing, Regulatory Affairs and Validation.
• Maintain QA oversight of development and stability activities.

Skills

cGMP

GDP

QMS

ICH Q8

ICH Q9

ICH Q10

Deviations & CAPA

Data integrity

Process validation

Equipment qualification

Job description

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-fundamental coordination skills.