Urgent opening For Formulation DQA (Assistant Manager )

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