JOB OPPORTUNITY - COMPLIANCE MANAGER - GSK

JOB OPPORTUNITY

Date Posted: 10-4-2020

Job Title: 

Compliance Manager

Organization: GSK

Location: 

Karachi, Paksitan

Job Purpose:

To perform Level-2 Audits and manage Regulatory sealed samples and the regulatory queries to promote Quality/Compliance within area of operations.

This role supports the Compliance Heads to ensure that the site's products continuously meet current regulatory requirements and major change projects get timely approval by regulatory authorities.

Responsibilities:

SUPPORT FOR  L1 & L2 AUDITS:

• Support for the preparation of Level 2 Audit Plan at Site.
• Participate in the on-site Level-2 audits
• Support and prepare the audit reports and communication to the auditee for the compliance.
• Receive, discuss & agree CAPA from the auditees.
• Ensure compliance to actions plans via follow ups with auditees.
• Plan and Participate Level-1 Audit of Compliance Department.
• Prepare the Level-1 Audit reports.
• Provide training on auditing skills.

SUPPORT FOR L3 & L4 AUDITS:

• Prepare for Level 3 and Level 4 audits.
• Support the compliance of QMS through Level 2 audits

REGULATORY COMPLIANCE:

• Support Compliance Manager in responding queries from local regulatory authorities within stipulated time.
• Provide technical information to regulatory affairs department as and when required.
• To Provide Support on technical information to Legal and Corporate Affairs Department in case of any query from Ministry of Health (e.g. Mis-branded, Counterfeit, Spurious, Substandard etc.).
• Provide the required support & documentation to the Company lawyer regarding the sealed samples when required.
• Management of the Regulatory Sealed samples.

QUALITY ALERTS:

• Management of the quality alerts and the responses.

Education & Requirements:

• B-Pharm/ Pharm-D or M.Sc.
• Must have an experience of at least 5-8 years

How to Apply:

Candidates should apply online by following link:
https://jobs.gsk.com/pakistan-pharma/jobs/248840?lang=en-us&previousLocale=en-PK

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