audit compliance – manager in vadodara

posted
contact
randstad india
position type
permanent
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posted
location
vadodara, gujarat
function
Pharma, healthcare & lifesciences
position type
permanent
experience
10 To 12
reference number
946205
contact
randstad india

job description

audit compliance – manager in vadodara

1 Take lead at site for preparation and execution of any external Regulatory/Customer/ThirdParty Audits with target of zero non-conformity. Coordinate with functional heads for planning & preparation of CAPA, its implementation & ensure effectiveness by closing them in timely manner.

2 Perform Due Diligence, GAP Asssessment, Trainings, cGMP review at all sites globally to ensure that sites are ready for any inspection at any given point.

3 Coordinate with all stakeholders for preparation and compilation of Data required by Regulatory Affairs Department for regulatory filings including registration of product, CAPA, customer responses and regulatory queries.

4 Lead the Internal Audits at site to ensure that the cGMP practices are followed, implemented at all level of organization. Also ensure the effectiveness of CAPA and its implementation adhering to global cGMP standards.

5 Carry out the Investigation of Deviations, Customer complaints, OOS and OOT and work on continual improvement of the overall Quality Management System.

6 Provide any support needed for making Standard Operating Procedures, Policies or any other Quality document as per the requirement

7 Any other responsibilities assigned by management from time to time



Benefits
A MNC

Client Introduction
A company which is a global leader in innovative chemistry and technologies.

skills

Audit, USFDA

qualification

Qualification: M.Pharm / M.Sc. Chemistry
Experience (in years): Min 10- 12 years with exposure to USFDA audits