Senior Manager Corporate Quality Auditor | Sun Pharma | Mumbai

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.