Title:  Senior Manager - 1 (QA Compliance)

Position:

Senior Manager 1

Job Grade:

G9A

Job Title:

Senior Manager, Compliance

Sub-function:

Compliance

Function:

QA

Skip Level Manager’s Title:

Vice president (Regional Head)

Manager’s Job Title:

Sr. GM (Site Quality Head)

Location:

Dewas SGO

No. of Direct Reports (if any)

4

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

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).