Quality Validation Consultant (Hybrid/Remote)

Proclinical is seeking a specialist in Quality Validation to provide technical support to validation, drug substance and product PPQ programs, both internal and external. This role will also provide work with internal facility and equipment qualification, CSV, Risk Management, and Data Integrity program. The successful candidate will be a member of the Quality Assurance team working closely with both internal and external partners to ensure compliance, strategies, and schedules within these programs. This position will report to the Associate Director, Quality Validation.

Job Responsibility:

• Provide Quality support to validation PPQ programs and strategies for both internal and external programs, including audit support/presentation and regulatory document review.
• Collaborate with partners in the development of validation protocols for facility, equipment qualification, cleaning/sterilization, and biological PPQ processes.
• Support of facility/equipment (internal), PV/PPQ, CSV qualifications/reports including amendments, CAPAs/deviations, risk assessments, and Data Integrity evaluations.
• Provide Quality Validation support for internal/external deviations and assessments for change controls.
• Investigate exceptional conditions during the execution of protocols, as well as other atypical events, deviations, OOS and non-conformances as required.
• Support continuous improvements projects related to QA and validation.
• Participate in risk assessments for both internal and external partners.

Skills and Requirements:

• BS/BA degree with 5-7+ years of pharmaceutical industry experience.
• Knowledge in development through commercial application, including biologic DS/DP process validation.
• Strong knowledge of FDA and EU regulations regarding the manufacture of biologics (FDA CFR Sections 210, 211, 610, 820 and Eudralex Vol 4; and related guidance; PDA, ISO and ICH)
• Expertise in quality systems, qualification / validation of facilities, equipment, processes (including cleaning/sterilization and biological PPQ) and CSV.
• Participation with internal and external audit support and regulatory document review.
• Excellent verbal & written communication along multiple disciplines.
• Demonstrated flexibility and agility in a rapidly changing environment.

If you are having difficulty in applying or if you have any questions, please contact Eloise Coly at (+1) 617-830-1627 or e.coly@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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