Website Asset Recruitment

Asset Recruitment

Job Summary
Reporting to the Head of CSQ/ENG QA, the QA Validation Specialist will be responsible and accountable for developing the QA validation procedures and ensuring compliance to legislative and local practices for the execution and documentation of all qualification/validation activities and QA related activities, e.g. document review and approval, to the release facility, utility and equipment for GMP production and testing.

Essential Duties and Responsibilities
• Responsible for preparing the quality review and ensuring QA approval of all qualification/ validation documentation, including computer system validation and associated data for conformance to regulations, Standard Operating Procedures (SOPs), specifications and other applicable acceptance criteria.
• Develop, write, review and approve SOPs and controlled documents to support the site qualification/ validation activities and in accordance with applicable standards, regulations and client requirements.
• Ensure all equipment and processes are safe, effective and qualified in compliance with industry standards and regulatory expectations.
• Review and gap closure of existing qualification documentation, as needed. Drive deviation management and provide oversight for qualification/ validation related deviations. Ensure corrective action / preventative action measures are implemented to drive improvement.
• Oversight for key functional areas (i.e. PEV, QC, Supply Chain, Engineering, CSV), ensuring that programs, policies and procedures are robust and in keeping with regulatory and client expectations. Providing clear expectations regarding validation standards. On-site monitoring of qualification/ validation activities to ensure correct execution and documentation.
• Lead by example and ensure associated risk assessments are conducted in line with site expectations and provide a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
• Liaise actively with other functional areas and provide support to ensure standards are met. Actively communicate with stakeholders and report issues within established reporting lines.
• Actively participate in internal and external audits as SME for validation processes and documentation. Represent the organisation in more complex risk and impact assessments.
• Perform all activities in compliance with applicable safety standards and SOPs
• Participate in other duties as assigned.

Technical Competencies
• Experience in facility, utility, equipment, computerized system qualification/ validation planning, execution and documentation.
• Experience with GMP processes like good documentation practice, change control, non-conformance management, corrective and preventative actions, and SOP writing.

• Minimum of 3 years’ experience working in a Biologics or similar GMP environment as part of an engineering, technical services or operations function or other combination of experience and educational background that may otherwise satisfy the requirements of the role
• Previous experience leading or coordinating established qualification/ validation teams, preferably working in a green field environment.
• Experience working in Quality Assurance role in a GMP Life Science environment.

• Demonstrated understanding of principles of Qualification/ Validation, including strong knowledge of Facility/ Utility/ Equipment Qualification, Computerised System Validation, Method Validation, Shipping Validation, Cleaning Validation and Process Validation.
• Strong knowledge of GxP regulations (e.g. EU-GMP Guideline, Annex 11/15, SFDA)

• B.Sc or B.Eng in a Scientific or Engineering related discipline preferred.

Behavioural Competencies
• Strong organisational, communication, coordination, and meeting facilitation skills
• Excellent interpersonal, verbal, and written communication skills
• Good critical thinking skills and troubleshooting to drive improvement and build opportunities
• Self-starter and self-motivated; organized with good attention to detail
• Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities
• Results oriented, with the ability to manage multiple priorities in a short period of time
• Collaborative and inclusive approach to work and your colleagues
• Engage cross functionally in conjunction with a site-based team

Further arrangements
This is a 6 months contractor role and the client can extend it for another 4 or 6 months with 2 weeks’ notice in advance.


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