Senior QA Specialist – Plant and Technical QA NPI/LCM-Dublin Contractor

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 

• 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.
• Quality review and approval of Technology Transfer, Qualification/Validation documentation and SOPs to support site activities:

DS, URS & QRAES documents

Validation Plans, Protocols, IQ, OQ, PQ and associated documents

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 

• 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.