Description

• Should possess sound knowledge of pharmaceutical manufacturing process (Non-sterile & Sterile formulations) & quality assurance regulations and auditing technique.
• To conduct the GMP audit of CMO/CNF/CWH sites of Sun Pharma located across the globe.
• 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.
• Should be able to travel across the globe for audits.
• 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.

Qualifications

Tenure : 10-15 Years in formulation & quality systems management operations.(Sterile Experience is mandatory )

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 .