Role & responsibilities

1. QMS & Quality Systems

- Own and harmonize QMS across R&D;, scale-up and manufacturing sites.
- Oversee Deviation, CAPA, Change Control, OOS/OOT and CAPA effectiveness.
- Standardize SOPs and quality practices across sites.

2. R&D; Lab QA Bench to Scale-up

- Establish quality controls, data integrity and documentation practices in R&D; labs.
- QA oversight of scale-up/pilot batches and technology transfer readiness.
- Review R&D; protocols, lab notebooks/ELN and analytical development data.
- Ensure robust impurity profiles, process parameters and control strategies.
- Drive risk assessment, QbD and DoE practices in R&D.;

3. DQA – Documentation Quality Assurance

- Own document lifecycle, control, reconciliation and archival for R&D; and plant.
- Ensure ALCOA+, GDP and data integrity compliance.
- Conduct documentation audits and training.
- Drive e-documentation and inspection readiness.

4. Regulatory & Audit Readiness

- Ensure readiness for USFDA, EU-GMP and WHO-GMP inspections.
- Coordinate audits, observations, 483 responses and CAPA.
- Implement ICH Q7, Q9, Q10 and Q11 requirements.

5. Product Quality & Technology Transfer

- Oversee APQR,



process/cleaning validation and analytical method validation.
- Provide quality oversight and approval for R&D-to-plant; technology transfers.

6. Supplier & Customer Quality

- Manage vendor qualification, audits, quality agreements and material risk assessments.
- Oversee market complaints, investigations and recall readiness.

Preferred candidate profile

- 15-20 years of experience in the API pharmaceutical industry.
- Mandatory exposure to First-to-File (FTF) or complex generic API development.
- Solid experience in Development QA (DQA) and Corporate QA (CQA).
- Hands-on experience with global regulatory audits and customer inspections.
- Sound knowledge of cGMP, ICH Guidelines, Data Integrity, Quality Risk Management, and Validation.
- Experience in technology transfer, commercialization, and DMF support.
- Excellent leadership, communication, problem-solving, and cross-functional stakeholder management skills.

Interested Candidates can mail CV on [email protected] or contact (phone hidden)

📌 DQA/CQA API-RND (Ahmedabad)
🏢 SynZeal Research
📍 Ahmedabad