Investigation Specialist

We are currently looking for an Investigation Specialist to join a leading Pharmaceutical company in the County Waterford area. As the Investigation Specialist, you will play a key role in quality investigations, committed to ensuring operational excellence and regulatory adherence.

This is an initial 12 month contract with possible extension.


KEY DUTIES AND RESPONSIBILITIES

Your duties as the Investigation Lead will be varied; however, the key duties and responsibilities are as follows:
 

1. As the Investigation Specialist, you will lead and coordinate investigations within the events management system, ensuring timely and compliant completion of each investigation.
2. As the Investigation Specialist, you will document investigation results accurately in the Phenix Event and CAPA Module and develop robust CAPA plans to prevent reoccurrence.
3. As the Investigation Specialist, you will support internal and external audits by providing investigative documentation and liaising with Subject Matter Experts (SMEs).
4. As the Investigation Specialist, you will provide training support to team members on investigation procedures and regulatory requirements.
5. As the Investigation Lead, you will ensure compliance with cGMP regulations and quality standards at all times.

1. A Degree or higher level in a relevant scientific or quality assurance field (e.g., Pharmaceutical Chemistry / Quality Assurance / Quality Management).
2. Extensive knowledge of cGMP within a regulated environment and understanding of quality systems.
3. Proven experience leading investigations and developing CAPA plans in highly regulated sectors.
4. Strong planning, organisational, and technical writing skills.
5. Excellent interpersonal and communication skills, with the ability to work independently and adapt to varying priorities.

Key Words: investigation / CAPA / cGMP / regulated environment / quality systems / audit support / technical writing / teamwork / compliance / investigation management / training / Investigation Specialist / Investigations / Audit / Good manufacturing Practice / Biopharma / Pharma / Biotech

"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career".

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.