Orion Group Life Sciences are currently recruiting a Senior Quality Assurance Specialist (PTQA) on behalf of our Multinational Biopharmaceutical client based in Dun Laoghaire on an initial 12-month contract (with potential to extend).
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.
Primary Responsibilities:
Quality point of contact and decision maker for Plant Deviations, CAPA's and EV's, ensuring that all activities meet company and regulatory expectations.
Quality point of contact and decision maker for Plant Change Controls, ensuring that all activities meet company and regulatory expectations.
Quality point of contact and decision maker for Process improvement projects including review and approval of Validation Protocols, executed validation documents and reports.
Quality point of contact for APR's.
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.
Preferred Qualifications:
University degree. Science or Engineering related discipline preferred.
Experience in change control, Deviation, corrective and preventative actions (CAPA's), CAPA Effectiveness verification, and validation practices.
Experience in aseptic manufacturing is preferred.
Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for Manufacturing
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.
Our role in supporting diversity and inclusion As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
