Title:  Senior Executive - Corporate Quality Audit (Packaging Material and CSP Audit)

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.