Senior Analyst

Location UK / Ulster

Job Type Permanent full-time, TemporaryContract

Salary Not disclosed

Updated 1 day ago

Reference 1370744

 Job Description

Overseeing the New Product Stability Laboratory Team the successful candidate will execute pre-approval stability studies in support of Pharmaceutical development and New Product Registration.

In Norbrook we pride ourselves in being one of the top 11 companies in Northern Ireland and in the top 15 veterinary pharmaceutical companies globally. We develop & manufacture veterinary medicines, supplying products to 120 countries globally. With a strong portfolio of existing products and significant investment in R&D to launch new products annually, we have opportunities for individuals to join us and develop their career in a global company.

Our business strategy is supported by our Values – Customer Value, One Team, Results Driven, Excellence, Innovation, and Quality – and we support our employees to live the behaviours that creates our culture.  Our on-going success is based on the expertise, knowledge and innovation of our employees. If you are interested in joining our team here at Norbrook and supporting our vision, then apply for this role.

 

Job Overview

Overseeing the New Product Stability Laboratory Team the successful candidate will execute pre-approval stability studies in support of Pharmaceutical development and New Product Registration. Ensuring all work is carried out in accordance with the Company’s Quality Manual, Standard Operating Procedures, and the quality standards set by the company. 

 

Main Activities/Tasks

  • To oversee New Product Stability Laboratory activities in support of Pharmaceutical development and New Product Registration, activities to include but not limited to:

o             Lab Scheduling, including daily huddles, in support of stability studies and ensure analysis of stability samples at scheduled time points

o             Review MoAs and support method transfer activities including compilation of reports

o             Ensuring the integrity of raw data for stability studies

o             Ensuring adequate documentation of laboratory work including CoAs

o             Support preparation of documentation for regulatory submission

o             Inform Line Manager/Project Management of the progress of stability studies

  • Oversee laboratory activities to ensure MoAs, SOPs, protocols, and GMP are being adhered to at all times
  • Oversee training of new and existing laboratory staff, maintenance of associated training records, and identification of training requirements
  • To oversee validation, calibration and cleaning of equipment as required, and identify equipment gaps within the group; highlight equipment failure or poor performance to Lab Coordinator/Section Head
  • Support preparation and review of Standard Operating Procedures, MOA’s and report books
  • Ensure a clean and safe working environment within the laboratories, following all COSHH and other Health and Safety requirements; liaise with the company Health and Safety teams as required
  • Maintain Laboratory schedule to ensure work is carried out in support of projects to agreed timelines
  • Coordinate with partner lines to effectively progress new product development and maximize resources (staff and equipment)
  • To maintain an awareness of current guidance’s (USP, Ph Eur, (V)ICH), and industry best practice for stability studies of pharmaceutical products activities
  • Any other duties as deemed necessary by management

 

Essential Criteria:

The successful candidate must possess:

  • A third level qualification in Chemistry or a related subject.
  • 2 years’ experience within a chemistry analytical laboratory including significant experience utilising HPLC/UPLC and Spectrophotometric techniques.
  • Good communication skills.
  • Good organisation skills and the ability to prioritise to meet the demands of a busy laboratory

 

Desirable Criteria

  • Bachelor degree or higher in a chemistry or pharmacy related discipline
  • Experience within a cGMP/GLP environment
  • Experience performing dissolution studies
  • Use of statistical analysis tools e.g. Minitab
  • Use of Design of Experiments

 

Duration: Full Time, Permanent

Location: Newry, Co. Down

Remuneration: Salary Attractive

Benefits: Free Life Assurance, Paid Holidays, On-site Parking, Pension Scheme, Canteen Facilities, Healthcare plan, Childcare Vouchers, Discounted Car Insurance, Perks Scheme

Contact: The Human Resources Department

Norbrook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy we would particularly like to welcome applicants from the Protestant Community.