Quality Assurance Specialist
The desired candidate should have a proven track record in QA leadership, and be comfortable working as part of a cross functional team.
Key Responsibilities:
- Quality Oversight of new equipment qualification:
o Provide overall quality direction for processes and procedures associated with all aspects of new equipment introduction, including Computerised System Validation
o Act as the Quality point of contact and decision-maker C & Q / Validation execution activities, ensuring all activities comply with regulatory and company standards.- Validation and Documentation:
o Quality review and approval of validation documentation, including:
- Design Specifications (DS), User Requirements Specifications (URS), and Quality Risk Assessments (QRAES).
- Validation Plans, Protocols (IQ, OQ, PQ), and associated reports.
- Risk Management and Compliance:
o Conduct risk assessments and develop mitigation strategies for potential challenges in equipment introduction.
o Provide input and quality oversight for change control development and implementation.
o Ensure timely and robust implementation of change controls and CAPA records.- Documentation and SOPs:
- Regulatory and Safety Compliance:
o Ensure all activities align with client's safety standards, SOPs, and regulatory expectations.
o Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations.
Preferred Qualifications:
- University degree in a Science or Engineering-related discipline.
- Minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry.
- Proven expertise in new equipment introduction, technical transfer, PPQ execution, and lifecycle management.
- Strong understanding of validation principles and regulatory requirements for C & Q / Validation (FDA, EMA guidelines).
- Experience with change control, non-conformance resolution, and CAPA implementation.
- Excellent organizational, communication, and collaboration skills.
- Ability to work independently with minimal supervision and operate effectively across functional boundaries.
- Critical thinking and problem-solving abilities.
Additional Skills:
- Familiarity with Quality by Design (QbD).
- Proficiency in statistical analysis tools (e.g., Minitab, JMP) is a plus.
- Team-oriented mindset with the ability to thrive in a collaborative decision-making culture.