Development Quality Assurance

xecutive – Development QA (DQA)

About [Company]

[Company] is a leading Contract Development and Manufacturing Organization (CDMO) and CRO based in Goa, providing end-to-end pharmaceutical development services including formulation development, analytical development, ICH stability studies, cGMP manufacturing, technology transfer, and bioequivalence studies for regulated markets. The organization has exposure to global regulatory standards including USFDA, MHRA, Health Canada, and other international agencies.

Position Details

Designation: Executive

Department: Development Quality Assurance (DQA)

Role Category: R&D

Experience: 2–4 Years

Qualification: M.Pharm / M.Sc

Location: Goa

Preferred Candidate Profile

1. Experience in Development QA (DQA)
2. CRO / Formulation Development background preferred
3. Exposure to OSD (Oral Solid Dosage) products
4. Experience working with regulated markets
5. Strong knowledge of QMS, GMP, and documentation systems

Job Responsibilities

1. Review and evaluate Stability Study Reports, DEC Reports, and Calibration Data Sheets.
2. Track, manage, and close QMS activities including:
3. Incidents
4. Deviations
5. Discrepancies
6. CAPA
7. Change Controls
8. Handle Change Control activities through Kriya as per established procedures.
9. Prepare and review Nitrosamine Risk Assessment and Elemental Impurity Risk Assessment reports.
10. Conduct and coordinate phase-gate review meetings and ensure timely closure of action items.
11. Manage item codification for Raw Materials, Packing Materials, and Innovator Samples in ERP.
12. Oversee RLD and Pilot Bio-sample Management.
13. Perform Audit Trail Reviews as per defined schedules.
14. Coordinate vendor intimation activities with QA as per SOP requirements.
15. Review, revise, and update SOPs as required.

Mandatory Skills

1. Development QA (DQA)
2. QMS Management
3. Change Control
4. CAPA
5. Deviation Handling
6. Documentation Review
7. Stability Documentation
8. SOP Review & Management
9. GMP Compliance
10. Audit Trail Review
11. Regulatory Compliance