Hovione is an international company with over 55 years' experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in Portugal, the U.S., Ireland and China, Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.
To reinforce our team we are looking to fill the following position at our Cork site:
The QA Specialist, required to work in an FDA / IMB approved GMP manufacturing facility, will be responsible for ensuring compliance to new and established systems and global regulations and guidelines for a wide range of complex active pharmaceutical ingredients and intermediates.
QA Specialist (QA)
- 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.
- B.Sc. Degree in a technical or scientific based subject - Chemistry, Biochemistry, etc.;
- Minimum of 2-3 years in a QA Specialist or Compliance Role in a Regulated Pharmaceutical Industry (API and/or DP manufacture);
- Competent and knowledgeable of all relevant ICH guidelines, particularly ICH Q7A, EU GMP guide annex 18, and all FDA requirements relating to 21 CFR 210 and 21 CRF 211;
- Excellent communications skills;
- Flexibility is essential;
- Proven ability to work on own initiative;
- PC skills MS Word, Excel, PowerPoint, MS Project, etc.
- Prioritises and plans for development;
- Builds relationships;
- Conveys Information Clearly;
- Clear understanding of Hovione's business & operations;
- Internal & External Customer Focus;
- Pursues, Applies & Shares Knowledge;
- Generates new ideas and diverse approaches;
- Organises and prioritises.
- Full time opportunity;
- Remuneration and social benefits adjusted to the job function and matching the experience;
- Excellent work environment, with a strong focus on quality.