Compliance Head

Position:

Senior Manager - Compliance Head

Job Grade:
G9A
Job Title:
Senior Manager, Compliance
Sub-function:
Compliance
Function:
QA
Skip Level Manager’s Title:
Manager’s Job Title:
Location:
No. of Direct Reports (if any)
Areas of Responsibility
1. Candidate should be well versed with the regulatory guidelines
2. Candidate should have shop floor experience of In-process control involving Non sterile and sterile operations.
3. Candidate should have experience in Validation, Qualification of equipment’s/instrument/software.
4. Candidate should be able to handle all QMS activities and should possess understanding of them.
5. Candidate should be well versed in driving the self-inspection and monitoring of CAPA till closure.
6. Candidate should be well versed in the software designed QMS, electronic controls and data management.
7. Candidate should be able to host the external audits, be versatile in spoken English and conversant with the various people specially during the inspection.
8. Candidate should be self-motivated and be able to lead the compliance of the site
9. Candidate should be a team player and should be able to drive collectively and in harmony.
Job Requirements
Educational Qualification
B. Pharm/M. Pharma.

Skills

Auditing skills
Experience
At least 15 years
USFDA/EU regulated market business sites experience