Job Overview
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Date PostedJanuary 16, 2023
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Location (State / UT)
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Expiration date--
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Experience18 Years
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GenderAny
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Desired QualificationBachelor Degree, Master’s Degree
Job Description
Job Summary:
- To conduct the audit of Quality Management Systems as per the Corporate Quality Audit program and provide support for compliance activities across all SUN Pharma Sites.
- To follow the Corporate Quality Policies, Global Quality standards, and applicable Regulatory Guidelines.
Essential Job Functions:
- To conduct the quality audit of manufacturing sites (Formulation and API) of Sun Pharma as per the schedule.
- To inform audit findings Lead Auditor / HOD and conclude the non-conformity against respective regulatory requirements.
- In the case of a lead auditor, coordination with the audit team and auditee, a compilation of audit findings, and a review of the audit report.
- Categorization of non-conformity into Critical, Major, and Minor appropriately.
- Prepare a draft audit report within 7 business days from the last day of the audit.
- To review & verify responses submitted by the site based on supporting evidence.
- Summarize the critical findings to the corporate quality audit head on a quarterly basis.
- Re-audit and conduct a surprise audit of the site, as and when required.
- To perform other duties and responsibilities as assigned by the head of the department.
- To raise the change control in case of deviations from the approved audit schedule.
- Participate and support project work as allotted by reporting authority.
Requirements and Qualifications:
Basic Qualification:
- Master of Science (M.Sc.) / Bachelor’s Degree in Pharmacy
Industrial Experience & Knowledge:
- 18 Years of Total work experience in the GMP environment of the Pharmaceutical Industry.
- Knowledge of cGMP and various regulatory agency requirements such as US-FDA, MHRA, TGA, ANVISA, etc.
- Strong organizational, interpersonal, and communication skills.
- Ability to work effectively in a multicultural matrix organization.
- Working knowledge and understanding of FDA/ ICH regulations in regulated environments such as 21 CFR, EU, TGA, Health Canada, MHRA, ANVISA, etc.
- Knowledge of cGMP and various regulatory agency requirements such as US-FDA, MHRA, TGA, ANVISA etc.
- Strong organizational, interpersonal, and communication skills.
- Ability to work effectively in a multicultural matrix organization.
- Working knowledge and understanding of FDA/ ICH regulations in regulated environments such as 21 CFR, EU, TGA, Health Canada, MHRA, ANVISA, etc.