Pharmaceutical Regulatory Affairs Specialist Omagh, Northern Ireland
Job description
Pharmaceutical Regulatory Affairs Specialist
Naturelle Consumer Products LTD was established in 1987 and is located in Omagh Co. Tyrone. The company employs approximately 100 employees and are a leading contract manufacturer of disposable contamination control and hygiene products for the medical, pharmaceutical and retail markets.
The company is actively looking to recruit a Pharmaceutical regulatory affairs specialist who has extensive experience in aseptic sterile manufacturing and is ready to take ownership of the companies regulatory requirements based on the principles of Annex1 GMP
This is an excellent opportunity to be part of the Senior management team within a leading, rapidly growing healthcare company who are well respected in the life science industry. This is a excellent opportunity to work with a pharmaceutical company in a highly strategic role as part of the senior leadership team. This is a cross-functional role with lots of exposure across the wider business with continuous development opportunities and a long-term career within a dynamic and stimulating environment. You will be working at the forefront by managing new projects in line with regulatory requirements
Responsibilities:
- Developing and implementing quality strategies to achieve quality goals and objectives
- Working closely with our external QPs to ensure regulatory compliance according to Annex 1
- Ensuring compliance to MHRA and EU GMP requirements as well as internal QMS policies
- Liaising with Manufacturing, Engineering and Validation departments to ensure the company meets quality expectations
Essential Criteria
- Minimum 2 years’ experience in Sterile Processing
- 3 years’ experience in Quality Management
- Strong experience within aseptic quality assurance and the management of systems
- GMP experience working on an aseptic or sterile manufacturing facility
- Experience within a leadership role
- BSc or MSc in a relevant Life Sciences subject
- Proficiency with computers, especially Microsoft Word and Excel.
- Excellent time management and organization skills.
Salary: Negotiable depending on qualifications and experience
Benefits
- Pension Scheme
- Save As You Earn Scheme
- Health Plan
Contact us to apply
Send your CV and a short cover letter using ref: 23-010, explaining why you’d make a good addition to our team, to [email protected], closing date is Tuesday 29th August 2023
Job Type: Full-time
Benefits:
- On-site parking
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Omagh: reliably commute or plan to relocate before starting work (required)
Experience:
- Sterile Processing: 2 years (preferred)
Work Location: In person
Reference ID: 23-015
