Title: Senior Executive - Corporate Quality Audit (Packaging Material and CSP Audit)
Date:
Nov 27, 2024
Location:
Sun House - Corporate Office
Company:
Sun Pharmaceutical Industries Ltd
Position: Sr. Executive (G11B)
Department: Corporate Quality Audit
Location: Mumbai
Reporting Manager Title: DGM- Corporate Quality Audit
Classification: Auditor: Packaging Material and CSP
Job Summary:
- GMP Auditor – Individual Performer Role (Packaging Material and CSP)
- To conduct independent corporate quality audit of quality management systems as per the Corporate Quality Audit program.
- Responsible for maintaining, updating status of Audit report, response, closure and upload to electronic module
- Technical Agreements management for PPPM and CSP
- Review “Annual Risk Assessment” received from Sun Manufacturing sites.
Essential Job Functions:
- Should possess sound knowledge of Vendor audits, Analytical Method Development, Method Validation/ Analytical Analysis technique, Analytical Method Verification and Analytical Method Transfer & quality assurance regulations and auditing technique.
- To conduct the GMP audit of Packaging Material vendors, Contract Service Providers (Testing and calibration Laboratories)
- Proactively identify the gaps during audits, connect the dots to ascertain systemic non-compliance and ensure compliance.
- To inform audit findings and conclude the non-conformity against respective regulatory requirements.
- Clear, precise and straight forward communication of identified non-compliances to the stakeholders along with risk associated with it.
- Categorization of non-conformity in to Critical, Major and Minor appropriately.
- To prepare audit report.
- To review audit response received from site to ensure effective and holistic implantation of CAPA.
- Capable to identify the systemic gaps proactively, based on the cGMP requirements, industrial practices and criticality of non-compliances cited by various regulatory agencies, etc.
- Maintain document related to audit and preparation of monthly report for audit function
- Accommodative to travelling.
- Basic computer skills (Microsoft word/ Excel/ Power point presentation) and ability to learn and become proficient with appropriate software.
- Should possess good verbal and written communication skills.
Basic Qualification: B. Pharm / M. Sc. (Chemistry)
Industrial Experience & Knowledge:
- Minimum work experience of 8-12 Years in Vendor audit/ Analytical & quality systems management operations.
- Exposure to regulatory agencies audits such as Schedule - M, USFDA, MHRA, ANVISA, TGA, WHO, ISO etc.
- Knowledge of Track wise/LIMS/SAP is desirable.
- Ability to work effectively in multicultural matrix organization.