- Work in an FDA / HPRA approved Drug Product Intermediate (DPI) and Active Pharmaceutical Ingredient (API) manufacturing facility.
- Ensure compliance to new and established systems, global regulations and guidelines for a wide range of DPIs, APIs and intermediates.
- Promote a mature quality culture.
- Issuance, control and review of production batch records.
- Review/release of all APIs; Pre-QP batch record review for DPIs.
- Lead and participate in validation activities including issuance of process validation protocols, reports and VMPs.
- Participate in cross functional teams for the introduction of new products/processes.
- Preparation/approval of cleaning documentation.
- Participate in cross functional investigations, advise on corrective actions and assist with their implementation
- Carryout GMP training.
- Participate in all aspects of audits by Regulatory Authorities and Customers
- Conduct internal audits as per agreed schedules
- Deputise in the absence of other Quality Assurance Specialists when requested
- To take reasonable care for your health and safety and for others in the workplace
- BSc in a technical or scientific based subject.
- Minimum of 5+ years in a QA Specialist, Validation or Compliance Role in a Regulated Industry (API/ Drug Product/ Biopharma, Medical device, etc)
- Competent and knowledgeable of all relevant ICH guidelines, particularly ICHQ7, EU GMP guide and other relevant guidelines
- Work as part of a team with an emphasis on continual improvement
- Flexible with excellent communication skills, ability to work on own initiative
- Knowledgeable in computerised systems validation is an advantage.
- Eligibility to become a Qualified Person is an advantage
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists