This is a 24-month contract with a view to extension. This is a hybrid position but the candidate needs to be commutable to the site.
Purpose
The Plant and Technical Quality Assurance (PTQA) Specialist is a senior position within the QA function which will typically report to a QA Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.
Responsibilities
1. Provide overall quality direction and oversight for processes and procedures related to Technology Transfer/NPI, Product Lifecycle changes, Validation, and Engineering ensuring that programs, policies, and procedures are robust and in keeping with regulatory and Company expectations.
2. Quality review and approval of Technology Transfer, Qualification/Validation documentation and SOPs to support site activities, including:
1. DS, URS & QRAES documents
2. Validation Plans, Protocols, IQ, OQ, PQ and associated documents
3. 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 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 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 Company Policies.
Perform all activities in compliance with Company 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.
Requirements
1. University degree. Science or Engineering related discipline preferred.
2. 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.
3. Understanding of principles of Validation and New Product Introduction.
4. Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
5. Ability to operate across functional boundaries, both internal and external.
6. Ability to work independently and remotely with minimum direct supervision.
7. Critical thinking skills.
8. Strong organisational, communication, coordination, and meeting facilitation skills.
9. Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.
10. Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
Skills:
Tech Transfer, NPI, Quality
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