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Quality Assurance Product Manager

Company: Catalent Pharma Solutions
Location: Saint Petersburg
Posted on: January 12, 2021

Job Description:

Position Overview:Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents , ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start hereQA Product ManagerSt. Petersburg is our primary soft gel development and manufacturing facility in North America with capacity of 18 billion capsules per year. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.The QA Product Manager provides customer service, with the highest integrity, focused on quality and compliance with partnership with Catalent St. Petersburg's customers and internal organizations. This position serves as a representative for their clients within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to: a) change controls and associated Master documents, including but not limited to MERs and material Specifications; Product specifications; Test methods; Master Batch Records; Master Shipper Labels; all equipment IQ/OQ/PQ documents regarding equipment, utilities, and computer systems; b) process improvement projects and Product Development Projects; c) all product process validation and cleaning validation documents; d) all Preventive Maintenance and Calibration work order requirements for critical systems, e) Investigations, CAPA and Root Cause Analysis (Manufacturing and Laboratory Investigations).The Role (daily responsibilities)* CUSTOMER FOCUS* Primary quality liaison for clients and internal customers. Is expected to become the Subject Matter Expert for the client products, processes and requirements.* Responsible for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus.* Effective coordination of functions across the site and with clients to drive timely review, approval, and closure of investigations, change controls, audit tasks, corrections, and effectiveness checks.* Generate quality metrics, trackers, and reports for management and clients to characterize the health of the client relationship and state of quality systems* TECHNICAL* Provide QA Technical recommendations based on trend analysis to eliminate future problems.* Facilitate CAPA commitments and Effectiveness Checks, including initiation, tracking, trending, and closure* Prepare and/or review investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure.* Collaborates with management and supervisory personnel from Operations, Quality Control and Quality Assurance to resolve problems affecting product quality; collaboration includes reacting, investigating and following up with ARD, Product Development and/or Operations for non-conformance issues and a working jointly towards resolutionThe Candidate (requirements)* Bachelors Degree in Science (Chemistry, Microbiology or Biology preferred) required* A minimum of five to ten years related experience and/or training and/or equivalent combination of education and experience in the QA pharmaceutical industries.* Prior experience working with validation, manufacturing or product development preferred.* Proven ability to multi-task and demonstrate diplomatic skills.* Must possess excellent English verbal and written communication skills.* Intermediate to proficient skills in Microsoft Office applicationsPosition Benefits* Cross functional exposure to other areas of Operations* Medical, Dental, Vision and 401K are all offered from day one of employment* 152 hours of paid time off annually + 8 paid HolidaysWe will identify candidates based on the following Catalent Competencies:* Leads with Integrity and Respect* Delivers Results* Demonstrates Business Acumen* Fosters Collaboration and Teamwork* Champions Change* Engages and Inspires* Coaches and DevelopsCatalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.personal initiative. dynamic pace. meaningful work.Visit www.catalent.com/careers to explore career opportunities.C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Keywords: Catalent Pharma Solutions, St. Petersburg , Quality Assurance Product Manager, Executive , Saint Petersburg, Florida

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