Job Description

ROLE SUMMARY This position is for assuring that all products released for supply and distribution (in India) are fit for their intended purpose. All systems and processes are in control so that the quality, safety and efficacy of the finished products are in accordance with the code of Good Manufacturing Practice (GMP), Corporate and Regulatory guidelines. Through partnering with local business units, internal stakeholders (supply chain, regulatory, medical quality etc.) Pfizer Global Supply (PGS) sites, External Supply Operations Quality and External Supply this position is responsible for ensuring a continuous supply of quality products, released for supply / distribution in accordance with regulatory and Pfizer requirements. In the absence of the Senior Quality Manager this role may act as the delegate. Job requires travel as per need basis. ROLE RESPONSIBILITIES Ensure compliance with Government regulations in relation to quality standards. Actively participate in the enhancement of the quality culture within Pfizer India. Review and approve critical documents according to the Quality Structure, Responsibilities and Decision-making matrix. Responsible for overseeing all disposition decisions for products received at CFA/HUB. Coordinate regular quality review meetings with the distribution warehouse quality unit. Ensure compliant systems are in place to manage and coordinate the following activities: Disposition of returned goods Product Quality Review Market Action/Recall Risk Assessment Deviations Change Control Repackaging & Relabeling Team training and competency. Drive team engagement, effective communication and development of team members by being available and present. Prepare and report on Key Performance Indicators and departmental activities in monthly management reports and required meetings. Compliance to all completion timelines such as and not limited to, change requests, actions, documentation updates and training. QUALIFICATIONS Bachelor\'s in pharmacy / Master\'s degree in science /Pharmaceutical science and 10 years of relevant pharmaceutical experience. Experience in Quality Systems in pharmaceutical, medical device, or combination product industry Excellent stakeholder and people management skills. Strong negotiations and effective communication skills. Strong technical experience with quality systems (change control, deviations, complaint management, documentation management, audits, inspections, etc.). Strong technical writing and presentation skills. Excellent written and verbal communication. Proactive approach and strong critical thinking skills Strong planning & organizing skills. Experience authoring, review, etc. of procedures or training materials. Experience leading project teams or staff. Advanced computer skills in MS Office applications and good knowledge of enterprise systems, such as PDM, Quality Tracking System Trackwise, Documentum platforms Work Location Assignment:On Premise Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Quality Assurance and Control #LI-PFE

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