Senior GMP Compliance Specialist

3 days ago


Mumbai, Maharashtra, India beBeeCompliance Full time

Role Summary:

We are seeking an experienced professional to lead our global risk-based audit strategy and program. The ideal candidate will have a broad background in pharmaceutical or medical device industry, with expertise in GMP auditing.

  • The role involves planning, leading, conducting, documenting, and following up on GMP audits according to Novartis Quality procedures and applicable regulations.
  • The leader will be responsible for auditing complex and high-risk sites and activities, providing technical guidance, mentoring, and training on audit activities.
  • They will also provide regulatory guidance for timely remediation and recommendations regarding acceptability of proposed filings.
Key Responsibilities
  • Establish strategic direction for the audit strategy and plan.
  • Plan, conduct, document, and follow up on GMP audits according to relevant quality procedures and regulations.
  • Audit complex and high-risk sites and activities.
  • Provide technical guidance, mentoring, and training on audit activities.
  • Assess adequacy of responses to audit findings in cooperation with QA stakeholders.
Essential Requirements
  • At least 15 years' experience in pharmaceutical or medical device industry.
  • Operational experience should include QA/QC management and manufacturing, development, or other relevant experience.
  • At least 3+ years auditing experience and excellent knowledge of regulatory requirements.
Desirable Requirements
  • Degree in Chemistry, Pharmacy, Biology, Engineering, or another related science.
  • Excellent oral and written English communication skills.

Benefits include significant travel opportunities and exposure to diverse experiences across different regions. As an expert in the field, you will contribute significantly to shaping the future of our organization.

This is an exciting opportunity to join a dynamic team and make a lasting impact on the company's success.


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