Senior QA Technical Support - NPI - Pharma

Orion Group Life Sciences have an exciting opportunity for a QA Technical Support - (QA TS) for our Multinational Pharmaceutical client in Dublin, Ireland on an initial 12-month contract.

QA Technical Support - (QA TS)

Job Description:
The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.

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 and regulatory expectations.
• Quality review and approval of Process Development and Validation documentation
• Technical transfer documents
• 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 the 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 (8yrs +) 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.

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.