Our client is a company with a focus on the development and manufacture of generic pharmaceutical products.

A key hire has opened up due to expansion. Real opportunities exist with this organization for the right candidate. Some travel is included with role. Previous experience of generics is essential for this post. A superb salary and working environment is on offer.

RESPONSIBILITIES

1. Management of QA team
a. Supervise all day-to-day activities of Irish QA team
b. Recruit new staff as required
c. Assign tasks to each QA team member and monitor performance levels.
d. Report on regular basis to the Quality Director and on a three-month basis to the wider group through the Quarterly Business Review process
2. General
a. Manage the preparation of Technical Agreements with new MAHs and CMOs, as required
b. Manage the central Auditing function between third party suppliers (CMOs and ASMs), MAHs and auditors. Maintain the Audit database and the rolling Group Audit Plan.
c. Qualify all GMP Third party suppliers used in R&D, and review Technical Transfer protocols, in conjunction with R&D, for new projects
d. Oversee the CMO compliance function
e. Manage the ongoing Product Stability program for all generic products. Build and maintain an electronic system to archive, approve, search and retrieve all product stability data.
f. Assist the R&D department and 3rd party suppliers in review and approve process validation and stability protocols. Liaise with other departments to ensure that all registration process validation and stability commitments are communicated to all parties and performed and implemented accordingly.

POSITION REQUIREMENTS

• Minimum Qualification: University/college degree, BA/BSc (life science preferred) or equivalent experience.
Preferred:
• MSc in Industrial Pharmaceutical Science and eligible for Qualified Person status.
• Minimum Experience: 10 years’ experience in a regulated environment (MUST include significant experience in GMP) in roles of a related discipline (e.g. Quality Assurance, Operations),
• Languages: Very good English (written and oral). Other languages are an asset.

ABILITIES

1. Proven leadership skills
2. Proven ability to manage complex quality issues and deliver solutions without endangering business continuity.
3. Proven ability to understand, analyze and communicate the impact of cGMP quality issues affecting the drug development process and supply.
4. Proven ability to work in multidisciplinary teams and ability to balance the requirements of cGMP with the business reality.
5. Flair for IT and good IT skills especially with Excel and Power Point.
6. Ability to contribute proactively to a continuous learning and process improvement environment;
7. Good capacity to react to and cope with unexpected situations and changing priorities;
8. Detail-orientated with the ability to check technical documents for accuracy and inconsistencies,
9. A wide knowledge of all aspects of the pharmaceutical industry is considered an asset. Previous experience in a manufacturing company is highly valued.


Contact Brian Christensen on 01 6854747 or submit your CV to brian.c@lifescience.ie for immediate consideration
If you would like further Information you can contact the recruiter directly:

Brian Christensen | Tel: +353 (0) 1 685 4747