Senior Quality Assurance Specialist

Team Horizon is seeking a Senior Quality Assurance Specialist to provide overall quality direction and oversight for key functional areas such as Packaging, Validation, Quality Control, Engineering, Automation & Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory and company expectations.

Why you should apply:

• Join a company with purpose, and the ability to discover, develop, manufacture and deliver innovative human therapeutics to pateints worldwide


• Work with a high performing team with start of the art facilities


• Flexibility around hybrid working

What you will be doing:

• Provide overall quality direction and oversight for processes and procedures


• Quality review and approval of Technology Transfer, Qualification/Validation documentation and SOPs to support site activities:
  o          DS, URS & QRAES documents
  o          Validation Plans, Protocols, IQ, OQ, PQ and associated documents
  o          Executed validation documents and reports


• Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Qualification/ Validation activities whilst ensuring that all activities meet and regulatory expectations.


• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulation


• Provide Quality direction and input at Change Control 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.


• Quality review/approval of BOMs, MBRs and recipes.


• Write, review and approve Standard Operating Procedures in accordance with Policies.


• Perform all activities in compliance with safety standards and SOPs


• In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role

What you need to apply:

• University degree. Science or engineering related discipline preferred.


• Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for NPI/ technology transfer / product lifecycle changes.


• 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.