Website Asset Recruitment
Reporting to the Head of QA for QC, the QA Specialist for QC will be responsible and accountable for oversight of the QC processes, activities and documentation, with main focus on the Modular Lab. This includes review and approval of qualification and validation documentation, as well as documents created in routine testing, regular walk-throughs and monitoring of lab operations for compliance with applicable standards and regulations.
Essential Duties and Responsibilities
• Responsible for the quality review of QC SOPs and monitoring of their implementation and adherence in the lab. Regular walk-throughs of the labs including monitoring of operations.
• Performs quality review and approval of QC documentation, e.g. forms, lab books, electronic documents, to ensure correct/ complete documentation and data integrity.
• Responsible for the quality review and approval of protocols, executed tests and reports for method qualification and validation.
• Support of QC in case of OOS investigations, deviation writing, root cause analysis, and CAPA definition and follow-up.
• Lead by example and ensure QC operation and documentation are performed by complying with all applicable standards, rules and regulations.
• Liaise actively with other functional areas, especially QC, and provide support/ advice to ensure standards are met. Actively communicate with stakeholders and report issues within established reporting lines.
• Actively participate in internal and external audits as QA SME for QC topics.
• Perform all activities in compliance with applicable safety standards and SOPs
• Participate in other duties as assigned.
• Experience in analytical testing, lab operations and documentation, preferably for biological products.
• Knowledge about analytical method qualification and validation.
• Experience with documentation, change control, non-conformance management, corrective and preventative actions in a GMP regulated lab environment.
• Minimum of 3 years’ experience working in a Biologics or similar GMP environment as part of quality, analytical lap or operations function or other combination of experience and educational background that may otherwise satisfy the requirements of the role
• Previous experience with quality systems and processes, preferably working in a green field environment.
• Experience working in Quality Assurance role in a GMP Life Science environment.
• Demonstrated understanding of principles of Good Documentation Practice and GMP requirements for training.
• Strong knowledge of GxP regulations (e.g. EU-GMP Guideline)
• B.Sc or B.Eng in a Scientific or Engineering related discipline preferred.
• 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
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.