Specialist Quality Control

NextPharma Technologies Holding Ltd; Livingston; On-site; GBP 28,000 - 52,000; Full time

Job summary

NextPharma Technologies Holding Ltd in Livingston, UK, is seeking a QC Analyst to support the production of development and market finished products under GMP. You'll work alongside Production and analytical teams to ensure quality.

The role requires practical experience with analytical techniques (HPLC, GC, Dissolution) and strong data reporting, with a proactive, team-focused approach; good communication and ability to work to tight deadlines.

Qualifications

• Understanding of drug development and manufacturing processes.
• Technical competence in analytical activities to prescribed quality standards.
• Skilled in analytical techniques e.g., HPLC, Dissolution, Gas Chromatography, and wet chemistry.
• 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.
• Broad knowledge and experience in a cGMP/GLP environment.
• Experience of quality control within a pharmaceutical environment.
• Experience of Chromeleon software and data reporting.

Responsibilities

• Work as part of a team alongside Production and analytical departments.
• Perform analytical activities to determine fitness for purpose of starting materials, intermediates and finished products.
• Technically competent in analytical activities for QC testing of materials and finished products under cGMP.
• Perform sampling of starting materials, packaging components and finished products.
• Perform cleaning verification analysis to assure suitability of production equipment.
• Support calibration of key analytical equipment and measuring devices.
• Comply with company health and safety procedures.

Skills

Analytical testing

HPLC

GC

Dissolution

Quality documentation

MS Office (Excel)

Data reporting

Team collaboration

Communication skills

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.

It's time for your next chapter:

We look forward to receiving your application.