Urgent opening For Formulation DQA (Assistant Manager )
MS Group · Hyderabad · onsite · Posted 58d ago
Undisclosed8–13 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- Experience: 8 to 13 years in FDQA.
- Qualification M Pharm or B.Pharm
- 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.
- 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
Sourced from naukri
Skills
FDQAmarket complaintsbprprocess validationdeviationCAPABmrGDPQMSGMPOOS/OOT Investigation
About MS Group
MS Group
₹3.5L PA avg
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