Job Description

NextPharma

NextPharma is a leading European pharmaceutical CDMO focused on attractive technology niches.

Since its foundation in 1989, the Livingston site has evolved into a global player in the development and application of both traditional and novel drug encapsulation technologies that are supported by modern and commercial scale manufacturing facilities. .

Our Vision:

Our vision is to be the leading and most trusted, reliable and innovative Europe-based CDMO by upholding the highest industry standards and exceeding customer expectations, while driving strong, sustainable growth for the company.

This role reports to the Quality Control Team Leader and will primarily be responsible for the conducting analytical activities, QC testing and release of materials, packaging components and finished products. The role will be responsible for providing technical expertise at both a theoretical and practical level. The ideal candidate will therefore have a pharmaceutical analysis background and have gained experience within a cGMP, FDA and MHRA regulated environment.

Job Purpose:

To support the production of both development and market finished products under GMP conditions in all areas of quality control and calibration.

Key responsibilities and accountabilities:

1. Work as part of a team alongside Production and other analytical departments including development and stability.

2. Actively involved in performing analytical activities to determine fitness for purpose of starting materials, intermediate and finished products

3. Technically competent in analytical activities (e.g., pharmacopeial wet chemistry, HPLC, GC, Dissolution) for QC testing of raw materials, packaging components and finished products. All activities to be performed under current cGMP, In house SOP's and/or pharmacopoeia

4. Perform sampling of starting materials, packaging components and finished products

5. Perform cleaning verification analysis to assure suitability of Production equipment for subsequent use

6. Support calibration of key analytical equipment and measuring devices used in or on production equipment

7. Comply with company health and safety procedures.

Person Profile: Quality Control Analyst

Personality:

Results oriented with a positive outlook and clear focus on high quality output: Solid planning and organizational ability; Reliable, tolerant, and dependable: Comfortable dealing with senior managers and customers: Enjoy working in a fast, stimulating environment. Goal-oriented: Able to work under pressure and meet deadlines; Excellent communication/ presentation skills. Able to get on with others and be a team player but equally comfortable working independently.

Personal Situation

Flexible and able to work extended hours when required.

Specific Job Skills:

Required:

Relevant qualification, HNC/HND/Science Degree or Equivalent

An understanding of drug development and manufacturing processes

Demonstrated technical competence of the technical and practical skills involved in analytical activities to prescribed quality standards

Skilled in analytical techniques e.g., HPLC, Dissolution, Gas Chromatography, and wet chemistry techniques

Able to communicate well with others, both laboratory and non-laboratory based

Able to work with minimal supervision.

Good understanding of quality control, SOP and GMP adherence

Desired:

Have a broad knowledge with and experience of working within a cGMP/GLP environment.

Experience of working within a pharmaceutical or biotechnology industry

Ability to work to key regulatory and compliance requirements

Experience of quality control within a pharmaceutical environment

Experience of Chromeleon software

Experience of data reporting and checking data within a QC environment

Understand and demonstrate a pragmatic approach to problem solving with GMP constraints.

Computer skills:

Must be competent in the use of MS Office, particularly Excel and Word,
e-mail and internet. Previous use of chromatographic acquisition software is desired but not essential.

Literacy and Numeracy:

Must be competent in writing reports both for internal use and for customers. Must be competent in the interpretation of analytical data.

Business Presentation Skills

: Must be an excellent face-to-face and telephone communicator

Interested? Please come to our open recruitment event on the 7th August at 5pm, bring a copy of your C.V. and meet the hiring team.

Please note: Only candidates with permanent Right to Work in the UK will be considered.

NextPharma is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership, pregnancy or maternity, religion or belief.

Job Types: Full-time, Permanent

Benefits:

Company pension Cycle to work scheme Free parking Health & wellbeing programme Life insurance On-site parking Private medical insurance Referral programme Sick pay
Schedule:

Day shift Monday to Friday
Work Location: In person