Job Description

Title

: QC Analyst (Stability)

Reports to:

QC Manager (Stability)

Based at:

Livingston, Scotland

Salary Range:

DOE

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 Stability Team Leader and will primarily be responsible for the conducting of stability analytical activitiesfor technical, clinical. and commercial products. There may also be a support function for QC, micro and analytical development departments. 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 on-going stability program for commercial, clinical and technical products. In addition support of quality control testing of both development and market finished products under GMP conditions

Key responsibilities and accountabilities:

1. Work as part of a team alongside quality control and micro departments

2. Actively involved in performing analytical activities for stability analysis of drug products

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

4. Writing of stability summaries, protocols and reports

5. Performing set down of new stability studies, receipt of stability samples being returned from storage facility and disposal of samples following reporting of analysis

6. Checking of data for stability, QC and micro departments

7. Ordering of lab supplies to ensure continued availability of materials for timely analysis

8. Comply with company health and safety procedures.

Person Profile: Quality Control Analyst (Stability)

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 is equally comfortable working independently.

Personal Situation

Flexible and able to work extended hours when required.

Must be eliglble to work in the UK.

Specific Job Skills:

Required:

Relevant qualification, HNC/HND/Science Degree or Equivalent

An understanding of drug development and stability processes

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

Skilled in analytical techniques eg HPLC, Dissolution, Gas Chromatography, KF 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.

2-3 years experience of working within a pharmaceutical or biotechnology industry

Ability to work to key regulatory and compliance requirements

Experience of quality control/Stability 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

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.

Remuneration Package:

Basic Salary: DOE

Private Medical Insurance

Health Cash Plan

Contributory pension scheme

Life Insurance

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, Temporary
Contract length: 6-12 months

Benefits:

Company pension Free parking Health & wellbeing programme Life insurance On-site parking Private medical insurance Referral programme
Ability to commute/relocate:

Livingston EH53 0TH: reliably commute or plan to relocate before starting work (required)
Work authorisation:

United Kingdom (required)
Work Location: In person