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M3-QAM-Quality Assurance Methods Generalist/Multidiscipline

Company: Catalent Pharma Solutions
Location: Philadelphia
Posted on: February 25, 2021

Job Description:

M3-QAM-Quality Assurance Methods Generalist/Multidiscipline Philadelphia, PA 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 here Position: Quality Assurance Methods Generalist/Multidiscipline Location: Philadelphia, PA Position Summary The following summary represents an ideal situation for a site with a high degree of operational excellence and a mature Quality Culture. Regardless, the Site Quality Director will implement strategies and tactical objectives to move the site towards this general model over time. General allocation of time, effort, and attention:

  • 30% Global leadership: working with the BU VP Quality and the other CSS Quality Directors to create and implement Business Unit quality strategy, global quality policies, BU quality process harmonization, etc.
  • 30% Site leadership: As a member of the Site Leadership Team working with the General Manager to create and sustain a site culture of Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility. Lead the development of site Quality Objectives, site Quality Plans, Quality Management Reviews, etc.
  • Overall responsibility for the site Quality Assurance and regulatory compliance functions including (but not limited to) those responsibilities listed below.
  • Oversee and execute all Performance Management Program (PMP) actions for the site Quality Assurance department. This includes professional development counselling, informal and formal performance appraisals and feedback, and talent development/succession planning.
  • 10% Personal Leadership: Professional development, managing work-life balance, strategic planning, etc. The Role
    • Internal Investigations on cGMP issues, trends, and customer complaints
    • Review and approve GMP documentation, including SOPs, Manufacturing Batch Records, validation protocols and reports, and executed Batch Records for cGMP compliance and clarity
    • Process integration and procedural harmonization with other CSS sites
    • Customer and Regulatory Audits, including coordination and submission of Catalent responses
    • Communication and escalation of quality issues to Site Leadership Team and QA senior management
    • Supplier and internal audits (including coordination with IACP program)
    • In-process QA activities, including line clearance and room release, in-process and receiving inspections, and raw material/product sampling
    • Implement Global quality policies and standards and CSS network procedures at the site
    • Continuous process improvements, particularly as a function of site deviation rate and recurrent deviation rate
    • Maintain robust relationships, interactions, and communications with client QA counterparts
    • Site Supplier Management Program. Provides guidance and direction for compliance with global SQM policy
    • Facility/equipment/process/analysis method/cleaning validation and qualification program Position Requirements
      • Knowledge and application ability for cGMP Regulation and Guidance for domestic and International Regulations for markets applicable to Catalent
      • Excellent interpersonal skills, including service mentality, active listening
      • Must be assertive without arrogance; confident without conceit
      • Ability to motivate, influence, and persuade colleagues up/down/and across the organization.
      • Articulate objectives, approach and business benefits for key stakeholders
      • Understanding of QA/QC GMPs and in interpreting and enforcing regulatory requirements
      • Comprehensive knowledge of regulatory organizations and requirements Education/Experience
        • Minimum BS Degree (or equivalent) in a Science, Engineering, or Pharmaceutical discipline.
        • Ten+ years of experience working in a chemical, pharmaceutical, food or relevant industry with at least five years' experience in QA/RA areas with progressive responsibilities.--
        • Experience in managing people, providing leadership, and implementing developmental plans for personnel.
        • Direct experience and working knowledge of Validation principles, including validation of processes, equipment, systems, analytical methods, cleaning, and transportation
        • Working knowledge of US and International cGMP regulations and experience working directly with the local and international regulatory agencies.
        • Experience with a variety of drug products and dosage forms. Knowledge/Skills
          • Must have a demonstrable record of implementing and maintaining quality systems; laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics
          • Successful development and implementation of a quality strategy for a manufacturing operations environment. Successful in implementing consistent standards
          • Experience in facilitating regulatory inspections
          • Strong understanding of the functional areas of manufacturing, sourcing, materials management and quality control
          • Understanding of QA/QC GMPs and in interpreting and enforcing regulatory requirements
          • Fluency in English required. Multi-lingual skills are preferred
          • Must be resourceful, possess strong time management skills and be able to work with minimal or no supervision to achieve deadlines and objectives. Catalent's standard leadership competencies that are used to interview and for Performance & Development:
            • Leads with Integrity and Respect
            • Delivers Results
            • Demonstrates Business Acumen
            • Fosters Collaboration and Teamwork
            • Champions Change
            • Engages and Inspires
            • Coaches and Develops Catalent 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. 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. Full time 0046118 About Us 0:00 / 1:45 Catalent = Catalyst + Talent Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us! personal initiative. dynamic pace. meaningful work. Catalent is the perfect place to grow your career if---
              • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
              • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year - more than any branded drug maker in the world!
              • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
              • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
              • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!
              • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here .--

Keywords: Catalent Pharma Solutions, Philadelphia , M3-QAM-Quality Assurance Methods Generalist/Multidiscipline, Other , Philadelphia, Pennsylvania

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