QA Validation Engineer

Location: Boston, MA
Department: Azzur of NE, LLC

Job Description

The QA Validation Consultant will be an integral contributor on our clients projects from start to finish on providing quality review of validation life cycle documents, including user requirement specifications, plans, protocols and reports in adherence with SOPs, corporate policies, standards and government regulations under the direction of Head, QA Validation. This role will provide vision, guidance direction and consultation to Engineering Qualification, Quality Control, MS&T and Process Unit personnel while reviewing and approving a wide range of validation life cycle documents. This role will provide quality requirements guidance to validation document authors to ensure high-quality documents that demonstrate consistent approach, in compliance with requirements. 

 

 Essential Duties and Responsibilities:

 

  • Collaborates with stakeholders, engineers, SMEs, and cross-functional team members in equipment qualification efforts.
  • Compliance review of GMP Documentation, including validation lifecycle documentation such as Impact Assessments, User Requirements, Design Documents, Traceability Matrix, Criticality Assessments, Risk Assessments, Part 11 Assessments, etc.
  • Review and Approve Validation plans, protocols, and reports for Facility, Utilities and Equipment (FUE) qualification.
  • Provide change assessments from a quality system documentation perspective for FUE.
  • Assist in the investigation and remediation of Protocol Discrepancies and Quality Events related to FUE qualification.
  • Assess Change Controls for Validation Impact.
  • Deliver Quality oversight to complex qualification activities and projects while providing timely review and approval of Equipment and Process validation plans, protocols, summary reports and deviations to ensure project timelines are not impacted.
  • Coordinates and develops with PU, MS&T, OPS and QC qualification projects and plans and identifies the RA critical to quality parameters impacting qualification activities, in accordance with the Site Validation Master Plans, Risk and Impact Assessments as appropriate.
  • Involved in review of Qualification and Validation life cycle documents revisions.
  • Authors/reviews/updates/assists in developing departmental standard operating procedures (SOPs) as well as QA review and guidance on asset change request in consultation with change request owners to evaluate validation impact.
  • Participates in continuous improvement and validation maintenance efforts.
  • Under the direction of the Head, QA Validation acts to create, implement and maintain up to date site validation compliance program and strategy.
  • Ensures that all activities are in compliance with cGMP, Health Authority regulations, qualification, and validation practices.


Minimum Requirements

  • Quality and Validation experience in the Pharmaceutical and/or Bio Pharmaceutical industries.
  • Bachelor’s degree in Scientific discipline or engineering related field with significant prior experience (3-7+ years) or equivalent.
  • General, 4+ years of validation in the Pharmaceutical industry experience required; or
  • 2+ years of Quality Assurance Validation or applicable experience in a related area in the Pharmaceutical industry.
  • Knowledge of cGMPs and understanding of the concepts of GLP, FDA and Health Authority Guidelines, applicable regulations and standards routinely used in the industry.



Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

 

Ideal Qualities:

Ideal candidates will exhibit, or have the willingness to develop, the following qualities:

  • Strategic thinker with strong analytical skills who can translate client needs into actionable
  • value-added projects/results
  • Understands the competitive landscape of the medical device, pharmaceutical, and
  • biotechnology industry
  • Willing to work hands on, assist with building client libraries, learn from a mentor and become
  • a mentor for others
  • Understands worldwide regulations and phase appropriate applications
  • Draws insights from projects and supplemental research to help drive new and existing
  • growth
  • Ensures activities are efficient, optimized, and client-centric
  • Highly motivated and organized, solutions-oriented leader
  • Curious and adaptable - has the ability to transform knowledge into actionable activities
  • Able to produce results in a fast paced, collaborative environment 

#LI-PP1 


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