Job Title:Manager - CMO (Audit)Business Unit:Global Quality & ComplianceJob GradeG10Location :MumbaiAt Sun Pharma, we commit to helping you “Create your own sunshine”- by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own Sunshine?As you enter the Sun Pharma world, you'll find yourself becoming 'Better every day' through continuous progress. Exhibit self-drive as you 'Take charge' and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we 'Thrive together' and support each other's journeys.”Job Summary :Manager CMO Quality - Individual Performer RoleTo conduct independent corporate quality audit of quality management systems as per the Corporate Quality Audit program.Key responsibilities:
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.
Travel EstimateJob RequirementsEducational QualificationM.Sc / B.Pharm / M.PharmExperienceTenure: 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.Your Success Matters to UsAt Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
