This company discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, this company was one of the first companies to realise the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. The company’s therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, the company remains committed to advancing science to dramatically improve people’s lives. The site, a 37,000 square metre aseptic drug product operations facility, specialising in secondary manufacturing activities – Formulation, Vial/Syringe Filling, Lyophilisation and Packaging. The site also includes laboratories and cold chain warehouse capabilities. There is a strong culture of continuous improvement and innovation to strive for solutions that improve health outcomes and dramatically improve people’s lives. The company is developing the capability to produce all its medicines in this site, helping to ensure continuity of supply of our medicines as they expand internationally.
The site provides state of the art working facilities, including Next Generation office areas and on site GYM. In addition they provide flexible working conditions, including flex hours and work from home. The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.
- Provide overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory and company expectations.
- Quality review and approval of Validation documentation and SOPs to support site validation activities: Review of DS & QRAES documents, Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents, Review of executed validation documents and reports
- Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities whilst ensuring that all activities meet company and regulatory expectations.
- Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
- Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
- Write, review and approve Standard Operating Procedures in accordance with company Policies.
- Perform all activities in compliance with Company safety standards and SOPs
- University degree. Science or Engineering related discipline preferred.
- Relevant experience (5yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems)
- Understanding of principles of Validation and New Product Introduction
- Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
- Ability to operate across functional boundaries, both internal and external.
- Ability to work independently and remotely with minimum direct supervision.
- Critical thinking skills.
- Strong organisational, communication, coordination, and meeting facilitation skills.
- Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.
- Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
For more information and a chance to apply please email me at email@example.com