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Pharmaceutical Development Analyst Newry, Northern Ireland

Norbrook Laboratories

Full Time Newry, Northern Ireland 33539 - 37996 GBP ANNUAL Today

Job description

In Norbrook we pride ourselves in being one of the top companies in Northern Ireland and
one of the top 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.

Pharmaceutical Development Analyst

Job Overview

The successful candidate will work as part of a cross functional R&D team and gain a broad
understanding of the processes involved in bringing new pharmaceutical products to market.
The analyst will perform chemical and physical testing of R&D batches in relation to method
development, validation and transfer of finished product methods as well as process validation
and stability study testing. The successful candidate will be responsible for the execution of
their daily tasks to meet overall project timelines and report results to a senior analyst in a
timely and accurate manner.

Main Activities/Tasks

Developing, optimising, validating, and transferring finished product methods of analysis

using a range physio-chemical techniques in accordance with relevant standard operating
procedures and regulatory guidelines and requirements.

Performing stability testing of R&D batches of finished product all in line with current GMP

and V/ICH requirements.

Assisting in the collection of samples from the production suites in support of

development/pre-approval and process validation batches and perform analytical testing
on same batches.

Assisting in trending of analytical data and in performing investigative analysis for out of

specification results in accordance with company procedures.

Ensuring all work is executed in accordance with Methods of Analysis, SOPs, protocols,

and GMP guidelines where required.

Adopting a GMP approach at all times and being mindful of data integrity requirements

when executing analysis and the corresponding recording of data.

Generating, interpreting and recording of data, results, draft methods, protocols and

reports pertaining to Method development, validation and transfer, alongside stability
studies and process validation of finished product.

Active problem solving, troubleshooting, and providing solutions to analytical challenges

during testing of finished product methods.

Conducting departmental training in all validated finished product methods as part of the

method transfer process.

Calibrating of relevant Laboratory equipment daily.

Ensuring the general H&S, cleanliness and tidiness of workplace and laboratory and assist

management team in always maintaining the laboratory in an audit readiness state.

Training or assisting in training new or existing personnel in laboratory techniques.

Taking responsibility for your continuing professional skill set necessary to operate within

the required competency level as per key skills matrix.

Essential Criteria:

Applicants must demonstrate the following essential criteria on their application form in order

to be considered:

Educated to degree level (or equivalent) in a science related discipline.

Previous experience working in or exposure to a cGMP environment (placements,

internships and work experience will be considered in lieu of paid experience).

Have HPLC, UPLC, GC and practical wet chemistry experience.

Have knowledge of VICH guidance for Method Validation of Finished product methods,

Process validation and Stability studies.

Desirable Criteria:

Due to the nature of the role preference will be given to applicants demonstrating the

following desirable criteria:

Possess a minimum of one years’ previous experience working in a GMP environment.

Demonstrable experience of working with Empower lab management system.

Previous analytical Method Development and Validation experience.

Finished product stability study experience.

Experience with troubleshooting relevant lab equipment; HPLC, UPLC, GC etc.

Duration: Full time, permanent.

Location: Newry

Additional Information:

This role will be based in a site that produces and handles penicillin, and as such, this

role would not be suitable for those that have a penicillin allergy.

Applicants should be able to provide proof that they have a right to work in the UK at the

time of their application. Applicants who are unable to provide this proof will not be
considered.

We regret that applications received after the closing date and time will not be accepted.

Benefits:

• Free Life Assurance • Employee Assistance Programme

• Company Pension Scheme • On-site free parking

• Healthcare cash plan • Canteen Facilities

• 32 days annual leave • Employee Perks scheme

• Wedding Leave • Discounted Car Insurance

• Company Sick Pay • Career development opportunities

Employee well-being initiatives

Contact: [email protected]

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.

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