Qualified Person - Biopharmaceuticals
Waterford, County Waterford, Ireland (Hybrid) · Contract
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- Experience
- 8+ yrs
- Salary
- —
- Openings
- 1
- Posted
- 3 hours ago
- Work mode
- Hybrid
- Education
- Degree in pharmaceutical sciences or related field
- Resume
- Required to apply
Where you'll work
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Job description
Overview
We are seeking a Qualified Person to join a prominent biopharmaceutical company located in County Waterford, Ireland. This position involves playing a vital role in ensuring the safety and compliance of pharmaceutical product releases within a global organization dedicated to advancing medicine and enhancing patient care.
This opportunity is initially a 12-month contract with the possibility of extension and requires availability for contract work five days per week. Hybrid working arrangements are available.
Key Responsibilities
- Oversee the batch disposition process to guarantee timely and compliant release of licensed pharmaceutical products.
- Ensure that all batch releases conform to site quality standards, regulatory requirements, and EU directives.
- Support and supervise deviation investigations, ensuring resolution prior to product release.
- Represent the Quality/Qualified Person function on cross-functional teams, offering quality assurance support across departments.
- Maintain autonomy and impartiality in decision-making concerning quality issues, adhering to industry best practices.
Candidate Profile and Requirements
- Degree or higher qualification in relevant scientific or pharmaceutical disciplines such as Pharmaceutical Chemistry, Quality Assurance, or Quality Management.
- Minimum of 8 years of experience operating in a current Good Manufacturing Practice (cGMP) environment, including previous roles as a Qualified Person responsible for licensed products.
- In-depth knowledge of sterile manufacturing processes, biologics, and clinical trial regulations is highly preferred.
Additional Information
This role is essential for ensuring regulatory compliance with agencies such as EMA, HPRA, and MIA. Candidates must demonstrate leadership capabilities and commitment to career development within the pharmaceutical industry.
Our recruitment partner is an equal opportunity employer supporting STEM sectors exclusively, encouraging applications from all qualified individuals.
Minimum education
Bachelor's Degree