Specialist Quality Control

NextPharma Technologies Holding Ltd; East Calder; On-site; GBP 26,000 - 38,000; Full time

Job summary

NextPharma Technologies Holding Ltd in the United Kingdom seeks an analytical specialist to support the production of development and market finished products under GMP. You will work in QC, perform analytical tests (HPLC, GC, wet chemistry), and assist with calibration and data reporting to ensure quality and regulatory compliance.

The role requires teamwork, good communication, and the ability to work under GMP constraints in a fast-paced environment.

Qualifications

• An understanding of drug development and manufacturing processes.
• Demonstrated technical competence of analytical activities to prescribed quality standards.
• Skilled in analytical techniques such as HPLC, Dissolution, GC and wet chemistry.

Responsibilities

• Work as part of a team alongside Production and other analytical departments.
• Perform analytical activities to determine fitness for purpose of starting materials and finished products.
• Carry out sampling of starting materials, packaging components and finished products.
• Support calibration of analytical equipment and ensure GMP compliance.
• Ensure adherence to health and safety procedures.

Skills

HPLC

Dissolution

Gas chromatography

Wet chemistry

Chromeleon software

Data reporting

Tools

Chromeleon software

Job description

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

Key responsibilities and accountabilities:

• Work as part of a team alongside Production and other analytical departments including development and stability .
• Actively involved in performing analytical activities to determine fitness for purpose of starting materials, intermediate and finished products
• 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
• Perform sampling of starting materials, packaging components and finished products
• Perform cleaning verification analysis to assure suitability of Production equipment for subsequent use
• Support calibration of key analytical equipment and measuring devices used in or on production equipment
• Comply with company health and safety procedures.

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:

• 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
• 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.

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.

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We look forward to receiving your application.