Role Description

On behalf of our client, a global pharmaceutical company, we are actively recruiting for the role of Project QA for their Global Product Supply division. My client is in the process of creating a new quality project organization in Global Quality. This organisation will be responsible for all the GPS projects that are driven or supported by Global Quality. Roles & Responsibilities: You will work closely with the project organisation and stakeholders to ensure that quality standards are implemented in each initiated project, ensuring effective communication and alignment on deliverables and timeliness. Your primary responsibilities will be: Supporting SME /QA, representing Global Quality in GPS projects. Ensure that quality standards are implemented in projects Assure ongoing compliance with quality and industry regulatory requirements You will in a global team and be in contact with numerous people in multiple departments and functions. Qualifications & Experience required for this role: Relevant 3rd level qualification in science discipline Master degree preferred but not essential Certifications are an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma, quality inspection, auditing and testing experience You should have several years of experience within the pharmaceutical industry and extensive experience with GxP/Quality. You are a self-starting and highly structured person who can get Quality on the agenda and deliver great results on time. Working cross-organisational takes effective communication and collaboration skills in combination with an open-minded and pragmatic approach that enables you to understand and respect different views and opinions. Excellent communication skills - verbal and written QA project experience Experience with implementation of corrective action programs For full spec and information email your CV to [email protected] or call Tina at +01 2784701    

On behalf of my client, a global CRO, I am recruiting for a Biopharma Chemist / Biopharma Scientist.  The successful candidate will perform a variety of complex sample preparation and analysis procedures to quantitatively measure small and large biomolecules such as proteins, peptides, nucleotides/oligonucleotides, DNA, carbohydrates / polysaccharides and liposomes using a wide range of analytical instrumentation. In this role you will work with minimal supervision, interpret analytical data with regards to acceptability and consistency and set up and maintain analytical instrumentation. Duties & Responsibilities include: •    Perform a variety of complex sample preparations •    Analysis procedures to quantitatively measure pharmaceutical compounds in a variety of formations for stability testing and other studies for analytical testing support •    Review and compilation of results •    Performing work assignments accurately, timely and in a safe manner •    Training on routine operation, maintenance and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines. Experience and Education: •    Education to a Bachelors or higher level in Biochemistry or related subjects •    3+ years’ relevant industry experience within a GMP laboratory (experience must be with Lab techniques relevant to Biopharm: ELISA, SDS-Page, Western Blot, HPLC, Capillary electrophoresis) •    Detailed knowledge of method validation; method development would be an advantage •    The ability to plan, schedule and carry out work for successful project completion •    A positive attitude and ability to work well with others •    The ability to write protocols and reports with minimum supervision •    Excellent attention to detail •    Be able to communicate effectively and follow detailed written and verbal instruction If you are interested in applying for this role please call Zoe on +353 1 2784671 or email [email protected] See the role at cpl.ie or click here Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com

See the role at cpl.ie or click here

On behalf of our client, a global CRO based in Mayo, we are seeking an experienced In-Vitro (Cell Culture/Virology) Supervisor for their Biologics Division. This role will be responsible for a Cell Culture/Virology Laboratory along with a team of 2-3 Analysts.   This main duties & responsibilities shall be:  

1. Oversee the quality of work produced by the Cell Culture/Virology team and ensure it is conducted in accordance with Standard Operating Procedures and the principles of GMP.
2. To implement and supervise safe working methods within the team and to inform and instruct staff of these. Comply with all Health and Safety regulations and procedures.
3. Develop, co-ordinate and implement training for staff on technical aspects of new and existing assays.
4. Responsible for providing feedback on performance to analysts working on Client specific projects.
5. Be involved in preparing costings and proposals based on protocols/project plan of proposed work by clients.
6. Assist in the transfer of assays from clients to the Department, where appropriate.
7. Participate in regulatory and client audits and liaising with clients as required.
8. Assist in the generation of appropriate SOPs.
9. Assist Project Leaders in research of technical information for incoming new enquiries.
10. Responsible for compiling audit responses in conjunction with the team and the Analytical Functional Manager.
11. Responsible for supporting staff with deviations and laboratory investigation reports.
12. Raw data review.
13. Responsible for ensuring all raw data and test results including protocols, reports etc are retained and archived according to Laboratories SOP’s.
14. Responsible for preparing ‘Presentations’ and the delivery of same to the Cell Culture/Virology team, other departments and to Clients as required.
15. Assist in Test Item Receipt (LIMS), Storage, Disposal and Decontamination.
16. Liaise with consultants and external services (e.g. subcontract laboratories) as appropriate.
17. Liaise with other departments to ensure that the laboratory areas and all equipment maintained in appropriate working conditions.
18. Responsible for purchasing new equipment and spare/replacement parts as required.
19. Responsible for maintaining stock of supplies (chemicals, consumables) needed for routine activities within the team.
20. Scheduling daily tasks to analyst, ensuring appropriate workload is not exceeded.

    The following are minimum requirements related to the In-Vitro (Cell Culture/Virology) Supervisor position.  

• BSc. In a relevant science discipline (e.g. Biology, Biochemistry or Biotechnology)
• A minimum of 3 years relevant experience in Scientific Research within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.
• Proven track record of supervising/managing staff.
• Experience in analytical techniques (e.g. HPLC, ELISA, Western Blot) essential.
• Ability to problem solve and work on own initiative.
• ·      Excellent communication and organizational skills.

If you are interested in applying for this role, please call Ciara on +353 1 2784671 or email [email protected]   Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com To view the job please click here or visit Cpl.ie