Senior Quality Assurance Specialist

Title: Senior Quality Assurance Specialist

Contract Length: 12 Months

Pay Rate: Up to €54- €58/hour

Location: Dun Laoghaire, Dublin, Ireland

Ask yourself this:

- Are you looking to join one of the world's leading bio-pharmaceutical companies?

- Are you looking for an opportunity to further your career within Quality Assurance in a senior position?

- Are you looking to further your career in an aseptic manufacturing GMP environment?

- Are you looking to join a team with great culture?

If yes, then this is the opportunity for you!

This is a great opportunity with a strong process and equipment validation background with a quality mindset and experience OR a candidate with strong quality assurance background with experience with New Product Introduction (NPI), Technology Transfer project experience and qualification of pharmaceutical manufacturing process.

The Role:

The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function and will be required to be a Subject Matter Expert in their assigned area of responsibility. The successful candidate will provide overall quality direction and oversight for processes and procedures related to Technology Transfer/NPI, Product Life-cycle changes, Validation and Engineering ensuring that programs, policies and procedures are robust and in keeping with regulatory and the company's expectations.

Some of the key responsibilities for the Senior QA Specialist will include:

• 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.
• 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 the site's and regulatory 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

Preferred Qualifications:

• 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 life-cycle 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, organised, 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.

Does this sound like you? If so, please apply today!

Get in touch to discuss this role!

My number is 020 7 551 0727

jkirlew@i-pharmconsulting.com