Quality Assurance Specialist

POSITION SUMMARY:

We are looking for a Quality Assurance Specialist to join our team on a 6-month contract. The Quality Assurance Specialist is responsible for
providing Quality Assurance oversight and support for commissioning,
qualification, validation, technology transfer, process lifecycle management,
capital projects, vendor qualification, and operational quality activities.
This role is accountable for maintaining quality and compliance throughout the
project lifecycle while supporting successful project execution and commercial
operations. The incumbent is also responsible and
accountable for the execution of the PSC mission, “to maintain the integrity
and professionalism of our products and services while enabling steady growth
and development”.

DUTIES AND RESPONSIBILITIES:

• Provide Quality Assurance oversight for
  engineering, validation, manufacturing, and capital project activities.
  
• Review and approve GMP-related documents,
  including validation protocols, qualification documents, risk assessments,
  technical transfer documentation, and quality system records.
  
• Support commissioning, qualification,
  validation, technology transfer, and process lifecycle activities to ensure
  compliance with regulatory and company requirements.
  
• Facilitate and support quality systems
  including deviations, investigations, change controls, CAPA, and risk
  management activities.
  
• Ensure compliance with cGMP, GxP, site
  procedures, and applicable global regulatory requirements.
  
• Provide quality guidance and risk-based
  decision-making to project teams and operational stakeholders.
  
• Collaborate with Engineering, Manufacturing,
  Validation, Quality Control, Supply Chain, and Regulatory teams to achieve
  project and business objectives.
  
• Participate in audits, inspections, and
  continuous improvement initiatives to maintain and enhance compliance and
  quality performance.
  
• Support vendor qualification and supplier
  quality activities as required.
  
• Additional duties and responsibilities may be
  assigned from time to time.
  

DEMONSTRATED COMPETENCIES:

• Quality &
  Compliance Excellence – Strong
  understanding of cGMP, GxP principles, quality systems, validation lifecycle
  requirements, and global regulatory expectations.
  
• Relationship Building – Works with and across
  formal and informal professional and social networks to build long-term
  partnerships and connections in the life science industry.
  
• Problem solving –
  Identifies, researches, and demonstrates logical reasoning to communicate
  critical information.
  
• Rational Persuasion –, Active listening, Presents key factors influencing factors, and
  strategic goals to assist stakeholders in identifying solutions.
  
• Interpersonal Awareness – Ability to be aware of
  how actions, ideas, and communication can/does affect people and their
  outcomes.
  
• Agility – Meets objectives by responding to competing
  and changing priorities and multiple tasks under inflexible timelines.
  

Requirements

      REQUIRED EDUCATION AND WORK EXPERIENCE:

•  Bachelor’s Degree in Engineering
  or Life Science.
  
• Minimum 2 years
  of experience in Quality Assurance, Validation, Manufacturing Quality, or
  Project Quality within the pharmaceutical, biotechnology, medical device, or
  other regulated industries.
  
• Demonstrated
  experience reviewing and approving GMP documentation including risk
  assessments, validation protocols, qualification documents, change controls,
  deviations, and CAPAs.
  
• Experience
  supporting technology transfer, process validation, qualification, engineering,
  manufacturing, or capital projects.
  
• Working knowledge of cGMP, GxP, FDA, EMA, TGA, PIC/S, and
  international regulatory requirements.
  
• Strong technical writing and document review skills.
  
• Ability to
  build and maintain relationships with stakeholders across multiple functions
  and organizational levels.