Specialist Quality Control

NextPharma; Livingston; On-site; GBP 32,000 - 42,000; Full time

Benefits offered by this job

Private Medical Insurance

Health Cash Plan

Contributory pension scheme

Life Insurance

Job summary

NextPharma is seeking a Quality Control Analyst (Stability) to support ongoing stability programs for commercial, clinical, and technical products. You will perform analytical testing under GMP conditions and contribute to data integrity and reporting.

The role requires a relevant science qualification, experience with HPLC, Dissolution, GC and KF, and the ability to work in a fast-paced environment while maintaining strict quality standards.

Qualifications

• Qualification: HNC/HND/Science Degree or Equivalent.
• Understanding of drug development and stability processes.
• Demonstrated competence in analytical techniques (HPLC, Dissolution, GC, KF, wet chemistry).
• Able to communicate well with others, laboratory and non-laboratory based.
• Good understanding of quality control, SOP and GMP adherence.

Responsibilities

• Work as part of a team alongside quality control and micro departments.
• Perform stability analysis of drug products.
• Write stability summaries, protocols and reports.
• Set up new stability studies and manage sample receipt and disposal.
• Check data for stability, QC and micro departments.
• Order lab supplies to ensure timely analysis.
• Comply with health and safety procedures.

Skills

Analytical techniques

Communication

Teamwork

Independent working

Education

HNC/HND/Science Degree or Equivalent

Tools

HPLC

GC

Dissolution

KF

Chromeleon software

Job description

• Relevant qualification, HNC/HND/Science Degree or Equivalent

Are you looking for... an exciting professional challenge?

We are one of the leading European contract manufacturers in the pharmaceutical, biotech and healthcare sectors, with some 2,300 employees in Germany, France, Finland, UK and Norway. For us, the next step is always the one that matters most. Our fast pace drives us forward, fills our working environment with life and spurs our growth. Our winning formula for shared success: room for passion. Because we know that passion is the best medicine when it comes to excellent service around the world. Welcome to NextPharma.

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

• Work as part of a team alongside quality control and micro departments
• Actively involved in performing analytical activities for stability analysis of drug products
• Must be 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
• Writing of stability summaries, protocols and reports
• Performing set down of new stability studies, receipt of stability samples being returned from storage facility and disposal of samples following reporting of analysis
• Checking of data for stability, QC and micro departments
• Ordering of lab supplies to ensure continued availability of materials for timely analysis
• Comply with company health and safety procedures.

Person Profile: Quality Control Analyst (Stability)

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.

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.

Required

Specific Job Skills:

• 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
• Must be 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

Please note: Only candidates with continuing 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.