Senior QA Specialist

We are seeking a Plant Technical Quality Assurance (PTQA) Specialist to join our clients team. This senior QA role is ideal for someone with a strong technical foundation in aseptic process validation, technology transfer and new product introduction.

Key Responsibilities

* Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet Amgen and regulatory expectations.

* Quality review and approval of Process Development and Validation documentation

o Technical transfer documents

o Validation Protocols, executed validation documents and reports

* 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.

* Perform all activities in compliance with Amgen 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

Preferred Qualifications

* University degree. Science or Engineering related discipline preferred.

* Understanding of principles of Validation and New Product Introduction

* Experience in aseptic manufacturing

* Relevant experience (7yrs +) 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, Manufacturing)

* 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.