Senior Pharmaceutical Compliance Auditor

4 days ago

Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 1,04,000 - ₹ 1,30,878
Compliance Expert Job Description">

The ideal candidate will have a proven track record of leading GMP audits to ensure compliance with regulations and standards. He or she must possess in-depth knowledge of pharmaceutical manufacturing processes, including sterile production, combination products, biologics, and more.

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Key Responsibilities:

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  • Develop strategic audit plans to drive compliance and quality excellence.">
  • Conduct on-site audits at complex sites and activities to identify potential risks and areas for improvement.">
  • Provide technical guidance and support to junior auditors to help them develop their skills and expertise.">
  • Ensure timely and effective remediation of critical findings through collaboration with stakeholders and the development of comprehensive CAPA plans.">
  • Review and advise on relevant policies and procedures to ensure alignment with regulatory requirements.">
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Requirements:

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  • A minimum of 15 years' experience in the pharmaceutical industry, with a strong background in QA/QC management and manufacturing.">
  • At least 3 years' auditing experience, with a solid understanding of regulatory requirements and industry best practices.">
  • Expertise in one or more areas, such as sterile manufacturing, laboratories, medical devices, API, excipients, or microbiology.">
  • Strong interpersonal and leadership skills, with the ability to facilitate cooperation and consensus among teams and stakeholders.">
  • Excellent analytical and problem-solving skills, with the ability to evaluate complex compliance issues independently.">
  • A degree in a related science field is preferred, although not required.">
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Benefits:

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  • Opportunities for professional growth and development.">
  • A dynamic and collaborative work environment.">
  • A competitive salary and benefits package.">
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Others:

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  • Maintain current knowledge of regulations and guidelines.">
  • Collaborate with stakeholders to develop and implement process improvements.">
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