Quality Assurance Specialist - Pharma
Company: RECRUITERS Agency
- Location: Carlow, Ireland
- Work mode: Hybrid
- Seniority: Mid level
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Quality Assurance Specialist
- Location: Carlow
- Contract: 11-month Fixed-Term Contract
- Working arrangement: Hybrid – 1–3 days per week onsite
- Start date: ASAP
We are recruiting a Quality Assurance Specialist to support a pharmaceutical manufacturing site in Carlow. The role will provide quality oversight and direction for the introduction of new equipment, including engineering, commissioning, qualification and validation activities. You will also support deviation investigations, change controls and quality risk assessments, ensuring compliance with applicable regulatory requirements and site quality standards.
Key Responsibilities
- Provide quality oversight and direction for the introduction of new equipment, up to and including validation activities.
- Conduct quality reviews and approvals of engineering, commissioning and qualification activities.
- Conduct quality reviews and approvals of validation, automation and utilities activities.
- Support deviation investigations and ensure timely close-out.
- Provide quality oversight of change controls related to the introduction, commissioning and qualification of new equipment.
- Provide quality oversight of quality risk assessments related to the introduction, commissioning and qualification of new equipment.
- Support site compliance by adhering to divisional policies, guidelines and regulatory requirements.
- Proactively evaluate site compliance against emerging trends and initiate compliance improvement initiatives.
- Participate in Plant/Quality committees and collaborate with other site functional groups.
Requirements
- A minimum of 3–5 years' experience in a Quality role, ideally within a pharmaceutical manufacturing environment.
- A Bachelor's degree or higher in a related Science discipline is preferred.
- Knowledge of regulatory and code requirements relating to Irish, European and International Codes, Standards and Practices.
- Familiarity with cGMP and GDP requirements.
- Experience with equipment and process validation.
- Familiarity with sterile filling processes and equipment.
- Strong continuous improvement mindset.
- Strong report, standards and policy writing skills.
- Proficiency in Microsoft Office and relevant job-related computer applications.
- Experience or familiarity with Lean Six Sigma methodology is desirable.
- Strong collaboration skills and the ability to work effectively as part of a team to determine priorities.
- Ability to work independently and take ownership of improvement initiatives with moderate guidance.
- Proven ability to drive tasks through to completion.
- Strong decision-making, accountability and problem-solving skills.
By applying here you agree to RECRUITERS storing your CV in our secure applicant tracking system (ATS; Bullhorn). As your consultants, we are dedicated to helping you find a new job in your field of expertise and, equally, to keeping your personal information secure at all times. Your CV will not be sent to any third party without your consent.
