Job Information
Sun Pharmaceuticals, Inc Senior Executive - Corporate Quality Audit (Packaging Material and CSP Audit) in India
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.
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.