****Must have a background in a pharmaceutical manufacturing environment – lab background is not suitable****
Overview:
We are exclusively partnered with a growing MedTech company in Athlone, Westmeath and are seeking an experienced
Quality Specialist
to join their growing team.
This is a great opportunity to join a growing medtech/pharma company that have just listed public on the Singapore Stock Exchange.
The successful candidate must be able to demonstrable knowledge of HPRA, EU and US GMP/GDP requirements and international guidelines governing pharmaceutical manufacturing and quality systems.
This is a permanent opportunity offering hybrid working once probation is passed.
Responsibilities:
* Provide quality support on manufacturing activities conducted at third-party sites.
* Contribute to Quality activities in a fast-paced dynamic team, including but not limited to SOP development, document control, deviation and CAPA management, and change control processes.
* Monitor investigation timelines for quality issues e.g. deviation and complaints
* Issuance and archiving of quality documentation.
* Report out key process indicators (Document Change Control, Complaints & CAPA)
* Carry out assigned internal and external audits.
* Aid in the investigation and evaluation of audit findings.
* Ensure root causes are appropriately identified and corrective actions are verified for effectiveness.
* Lead for the training processes and procedures across the business to ensure training is administered in line with the Company Training Procedure and records are maintained.
* Review records and documents for completeness and compliance with GMP/GDP requirements and internal organizational procedures.
* Assist in the development, implementation, and continuous improvement of the Quality Management System (QMS).
Essential Criteria:
* Bachelor's Degree in a Science Related Discipline
* Minimum of 3 years in a quality assurance or compliance role within the
pharmaceutical industry.
* Team Oriented: Ability to integrate with the Company Core Values, culture, and team climate.
* Self-Motivated: Identifying what needs to be done and doing it before being asked or before the situation requires it.
* Must hold Stamp 4 Visa or EU Passport.
If this
Quality Specialist
job in
Athlone
is of interest to you apply now or contact David Smith at Collins McNicholas Recruitment to learn more.