Senior Quality Assurance Professional – Technical Support – REF NHA00

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.

This is a Dublin based role within a leading biopharmaceutical multinational.

Key Responsibilities

 

·         Provide overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems)

·         Quality review and approval of Process Development and Validation documentation

·         Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities whilst ensuring that all activities meet site and regulatory expectations. 

·         Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations

·         Provide Quality direction and input at Change Control Review Board and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely. 

·         Write, review and approve Standard Operating Procedures in accordance with site Policies. 

 

Preferred Qualifications

•        University degree. Science or Engineering related discipline preferred. 

•        Understanding of principles of Validation and New Product Introduction

•        Relevant experience (5yrs +) 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, Quality Control, Supply Chain, Engineering, Information Systems)

•        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.

 

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