Quality Investigation Specialist
Pharmaceutical Product Development, LLC
PA
hace 33 días

EXPECT MORE FROM YOUR CAREER

EXPECT PPD

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP.

PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical / biopharmaceutical company, all while maintaining full-

time benefits / advantages of being a part of PPD. As a Quality Investigation Specialist on the client site you will be responsible for monitoring and supporting the quality performance of contract manufacturing organisations (CMOs) and material / service suppliers to ensure that all operations are fully in compliance with current international standards for cGMP.

Specifically, this position is responsible for Quality oversight of CMOs / vendors of our client's Investigational Medicinal Product, used in our client's sponsored clinical studies in support of new product introduction and existing product development during lifecycle management.

You will also be responsible for developing and maintaining Quality Systems and Vendor Management activities.Responsibilities :

  • Lead and / or support quality oversight of our client's GxP contractors as required including manufacturing, analytical testing, packaging and distribution.
  • Monitor daily operations at the contract site including batch review and disposition, review of stability data, deviations, OOS investigations, change controls, complaints and other quality systems.

  • Oversight of non-routine manufacturing / packaging activities at the contractor site.
  • Work with and ensure compliance with the GxP vendor qualification programme including initial and ongoing qualification to ensure quality oversight of GxP Vendors.
  • Act as lead auditor in third party vendor audits as per the client's audit schedule.
  • Be a key member of company audit team during regulatory or customer audits. Ensure a state of constant readiness for unannounced regulatory inspections.
  • Support the execution of the internal Quality Management System (QMS) to ensure compliance to all relevant standards within the company, including, but not limited to Product Complaints, Deviation & CAPA, Out-
  • of-Specification Investigations, Change Control, Product release for distribution, Internal Audit, SOPs and Controlled Documents, Training, Artwork approval, Validation and qualification.

  • Contribute to the development of quality policies and procedures and participate in the internal audit programme, which serves to verify adherence to and compliance with the requirements set out in these controlled documents.
  • Provide QA and technical support to key company pre-and post-approval development activities such as : Manufacturing site transfers and process scale-
  • up; Product life cycle maintenance activities and new product launch; Analytical method qualification & method transfer; Integration activities following product acquisition and Product formulation development.

  • Build authentic relationships and lead business meetings and audits of critical suppliers and contract manufacturers and maintain all product-
  • related Quality Technical Agreements (QTA’s).

  • Participate in and provide critical analysis of business diligence visits.
  • Other Responsibilities :

  • Work closely with other members of the client's Technical Operations group to ensure delivery of key project objectives and timelines
  • Work directly with other key Client Company departments to ensure compliance and productive working relationships.
  • Assist with troubleshooting quality issues at Partner’s or vendor’s site, when required.
  • Integrate, contribute, and / or lead cross-functional project teams as required. Support projects schedules as required.
  • Foster a positive employee relations environment and a culture of continuous improvement and teamwork through the use of good and consistent management principles.
  • Qualifications

    Education and Experience :

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
  • Knowledge, Skills, and Abilities :

  • Significant experience (5-10 years) working in finished product pharmaceutical / biologics, including validation, analytical chemistry, quality assurance, quality control, development, and / or manufacturing areas is required.
  • Experience in the following desirable : Biological / Sterile product manufacturing, both clinical and commercial.
  • Experience with development / phase appropriate GMP is desirable.
  • Eligibility to act as a licensed Qualified Person is extremely desirable.
  • Thorough understanding of Quality Systems and cGMPs.
  • Experience with and fundamental understanding of FDA / EU regulations, associated guidance documents and in interfacing with regulatory bodies or working on regulatory submissions
  • Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, partners and colleagues.
  • Experience working with contract manufacturing organisations
  • Highly organised, with exceptional time management and prioritisation
  • Critical thinking and evaluation of process problems
  • Patient and results focused
  • Good Leader and highly motivated.
  • Collaborative team player
  • Strong work ethic with a flexible and adaptable approach
  • Excellent verbal, written and presentation skills
  • Exceptional ability to work with others
  • Great time management, planning and organizational skills
  • Outstanding critical thinking skills to support quality decision making
  • Excellent analytical skills and / or knowledge
  • Superb understanding of root cause analysis and CAPA
  • Working Conditions and Environment :

  • Exposure to high pressure, intense concentration needed
  • Must pay constant attention to detail-visual, mental
  • Must be able to multi-task constantly
  • Frequent interaction with clients / associates required
  • Long, varied hours required occasionally
  • Travel and rotating shifts required on rare occasions
  • Exposure to toxic materials on rare occasions
  • Physical Requirements :

  • Frequently stationary for 6-8 hours per day.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
  • Frequent mobility required.
  • Occasional crouching, stooping, bending and twisting of upper body and neck.
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Frequently interacts with others to obtain or relate information to diverse groups.
  • Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.
  • Requires multiple periods of intense concentration.

  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
  • Ability to perform under stress. Ability to multi-task.
  • Regular and consistent attendance.
  • PPD is an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group.

    Primary Location

  • North America-United States-Pennsylvania-FSP2 Philadelphia, PA
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