Job Title: Manager – Corporate Quality Strategy
1. Responsible for data integrity compliance at sites.
2. Have adequate knowledge about GMP guidances.
3. Ensure that Quality systems are in sync with current regulations by sharing updated regulatory guidance to all PEL sites via Quench update.
4. Updating sites about warning letters and ensure compliance against each observation across PEL sites.
5. Should have adequate experience in handling projects which are strategic in nature such as QUEST, Customer Centricity, 24/7 Audit Readiness at sites, Data integrity Compliance etc.
6. Review sites data on process capability ,OEE etc
7. Preparation and updation of Corporate Guidelines.
8. Support in preparation and conduct of Global Quality Meet.
9. Support site and corporate quality team in various projects.
- 6-10 years on industry experience in GMP environment.
- Experience in QA, R&D (API and / or Formulation) with technical expertise.
- Sound regulatory exposure.
- Good communication skills (Verbal & written).
- Adequate experience in handling data integrity audits. Aware about DI requirements and recent trends and expectations of regulators
- Experience Conduct of Site audits
- GMP knowledge
- Experience in working in Corporate Quality
- Risk Management and Investigation handling expertise
- Should be aware of Regulations of formulation and API
- Have faced regulatory inspections and should have experience in making Site Audit ready
Education:UG -B.Pharma – Pharmacy
PG – M.Pharma – Pharmacy
Doctorate – Doctorate Not Required