Department Head - Quality Assurance - Pharmaceutical (18-25 yrs)

Key Criteria:

1. The candidate must demonstrate the ability to independently manage their role and should have served as the Head of Department (HOD) for a minimum of two years.

2. As this position involves site responsibilities and interaction with a global team, the candidate is expected to have reported to a global or corporate function in India during their current or previous employment.

3. The candidate should possess substantial experience in the API sector and must be proficient in English, Marathi, and Hindi.

Roles & Responsibilities:

1. The establishment of a Quality Management System alongside cGMP/cGLP/GDP practices at the facility, in accordance with regulatory requirements and peptide policies.

2. Leading and preparing for audits and inspections by regulatory authorities.

3. Overseeing quality audits of potential partners and vendors to meet local and global regulatory standards and policies.

4. Playing a crucial role in audits to guarantee no critical observations are noted.

5. Ensuring the manufacturing site is audit-ready for inspections by the USFDA, EU, customers, and other regulatory bodies.

6. Verifying that document such as SOPs, validation protocols, reports, batch records, and master formula records comply with regulatory standards.

7. Investigating and resolving critical deviations effectively.

8. Providing training to personnel on quality systems.

9. Ensuring that internal audits (self-inspections) are conducted regularly.

10. Composing quality reports, manuals, and policies.

11. Developing a team of motivated, knowledgeable, and skilled quality professionals to foster a culture of total quality.

12. Conducting periodic reviews of procedures that affect the quality of intermediates or APIs.

13. Reporting key performance indicators related to quality assurance.

14. Managing the estimation of the department's budget and overseeing recruitment efforts.

15. Handling the licensing processes for local and central FDA.