Senior Plant Technical Qa Specialist

Description:

The Plant 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

* 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 Client 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 Client 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.

* 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.


Desired Skills and Experience

Validation , New Product Introduction, Quality Assurance,Process Development, Technology Transfer, Process Validation