Senior QAV Specialist

Location: Boston, MA
Department: Azzur Consulting LLC

Job Description

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!

Responsibilities: 

  • Lead and oversee the commissioning, qualification, and validation activities related to pharmaceutical manufacturing and facility systems, including process equipment, utilities, HVAC, cleanrooms, and automation systems.
  • Develop and execute validation protocols (IQ, OQ, PQ) and associated documentation, ensuring compliance with regulatory requirements and industry standards.
  • Conduct risk assessments and impact assessments to determine the criticality of systems and equipment, identifying areas that require validation and ensuring appropriate validation strategies are implemented.
  • Provide technical expertise and guidance to cross-functional teams on validation requirements, best practices, and compliance issues.
  • Collaborate with internal stakeholders, including Quality Assurance, Engineering, Manufacturing, and Regulatory Affairs, to ensure alignment and adherence to validation procedures and timelines.
  • Perform qualification activities, including equipment installation, operational testing, performance testing, and cleaning validation.
  • Analyze validation data, generate validation reports, and document any deviations or non-conformances, implementing corrective and preventive actions as needed.
  • Stay up-to-date with current regulations, industry trends, and technological advancements related to validation practices, ensuring compliance and suggesting process improvements when appropriate.
  • Participate in regulatory inspections and audits, providing support and documentation as required.
  • Mentor and provide guidance to junior validation engineers, promoting professional development and knowledge sharing within the team.


Qualifications and Experience:
 

  • Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related field.
  • Minimum of 6-10 years of experience in commissioning, qualification, and validation activities within the pharmaceutical or biotech industry.
  • In-depth knowledge of regulatory guidelines and requirements, including FDA, EMA, and ICH guidelines.
  • Strong understanding of validation methodologies, such as risk-based validation, process validation, cleaning validation, and computer systems validation.
  • Experience in authoring and executing validation protocols (IQ, OQ, PQ) and generating associated documentation.
  • Proficient in utilizing validation tools, software, and statistical analysis methods.
  • Excellent problem-solving skills and attention to detail, with the ability to analyze complex data sets and identify trends or deviations.
  • Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and present validation findings to stakeholders.
  • Experience working in a GMP-regulated environment, with knowledge of cGMP principles and industry best practices.
  • Professional certifications such as Certified Validation Professional (CVP) or Certified Quality Engineer (CQE) are desirable.
  • Experience with custom equipment validation a huge plus.

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