Job Description

Core Responsibilities Lead a team , trains others, handling of change control & Quality Risk Management process, leads significant or multiple projects Manages own time to meet objectives, forecasts and plans resource requirements (people, financial and technology) for projects across department. Develops goals and objectives for the team to obtain maximum efficacy from department including delivery of cost saving initiatives. Responsible for ensuring operating state of cGMP compliance in Manufacturing operations. Should have leadership qualities with trouble shooting abilities, which helps the organization to develop, implement and achieve its mission, vision and values. Provides guidance to and may lead moderate to complex projects. Responsible to train the colleagues with respective Change control and QRM. Attending issues related to change controls and QRMs and provide solutions as per the GMP norms. Responsible to build & maintain quality assurance oversight that support the manufacturing activities by reviewing and approval /authorization of quality operational documents. Provide necessary support to the Manufacturing, Quality control, MSAT, Regulatory Affairs, Validation and technology transfer projects. Conducting change control review board (CCRB) meeting with cross functional team to assess the changes before initiation in gQTS and present the critical change controls to the leadership team for it is adequacy. Assessment, approval & closure of change control and action items. Report any non-compliance. Core Competencies Change Management process. Risk assessments principles and tools. Validation of manufacturing equipment\'s and Lab equipment\'s Drug Product Process validations. Regulatory requirements Compendial Changes Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients. What You Will Achieve You will be a member of Pfizer\'s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer\'s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies. As a Team lead, you will be involved in leading work teams within a division. You will lead the people, technical and financial resources of the team. Thanks to your technical skills, you will coach your direct reports on day to day activities. You will be relied on to solve complex problems within your area of expertise. It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It Manage multiple projects and ongoing work activities in the department typically involving cross-functional representatives. Supervise quality personnel and activities associated with production processes through manufacturing and packaging. Initiate investigations, corrective and preventative actions when required. Maintain and revise Document Control Standard Operating Procedures for process improvements. Supervise and audit systems for the comprehensive training of area personnel and assign audit records to auditor. Requires comprehensive knowledge of GMPs, applicable SOPs and production processes, and statistical/inspection practices. Develop goals and objectives for the quality assurance team to obtain maximum efficacy from department including delivery of cost saving initiatives. Provide Quality Assurance review and final approval on Investigation CAPAs (Corrective Action and Prevention Action). Manage timely completion of investigations to support production operations. Manage and coordinate all quality functions through Pfizer Quality Systems. Supervise the Aseptic Service Workers to ensure proper cleaning and sanitization of the aseptic cores and controlled environment areas. Direct training and supervision of documentation personnel, distribution of all Standard Operating Procedures, Specification Sheets, Data Sheets and Batch Records etc. for the plant operations. Qualifications Must-Have B. Pharm/M. Pharm/M.Sc. 10 - 15 years of experience in Quality Assurance / Quality control/MQA of sterile dosage manufacturing facility. Advanced analytical skills will be required to make competent decisions based on a review of analytical data. Demonstrated leadership qualities with trouble shooting abilities in manufacturing area. Quality operations technical knowledge. Strong people management experience. Effective communications skills required, both written and verbal. Requires strong interpersonal skills and the ability to handle multiple projects. Nice-to-Have Master\'s degree Relevant pharmaceutical experience. Experience using data analysis computer tools and statistical analysis Knowledge of production operations and analytical data records Knowledge of Laboratory Information Management System Empower, and Microsoft Office programs 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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