Manager - Cmo Audit

4 weeks ago

Mumbai, Maharashtra, India Sun Pharmaceutical Industries Full time

Job Title Manager - CMO Audit Business Unit Global Quality Compliance Job Grade G10 Location Mumbai At 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 Role To 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 Estimate Job Requirements Educational Qualification M Sc B Pharm M Pharm Experience 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 Your Success Matters to Us At 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

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