QC Validation Engineer

At Coalesce Management Consulting, we are a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists.

Position: QC Engineer

Job Description:

We are currently expanding our team and are looking for a QC engineer on site with a client. In summary, you will be supporting the validation and lifecycle management of computerized systems and analytical laboratory equipment within a GMP-regulated pharmaceutical or biotechnology environment.

Key Responsibilities:

• Lead and execute CSV activities for analytical laboratory computerized systems and associated software applications.
• Develop, review, and execute validation documentation
• Support qualification and validation of laboratory instruments and systems such as HPLC, UPLC, GCLC-MS, UV-Vis Spectrophotometers, Dissolution Systems, Karl Fischer Titrators, TOC Analyzers,
• Perform impact assessments and validation activities for system upgrades, patches, configuration changes, and software migrations.
• Ensure compliance with ALCOA+, Data Integrity, GAMP 5, 21 CFR Part 11, Annex 11, and company quality standards.
• Review and approve vendor qualification documentation where applicable.
• Support deviations, investigations, CAPAs, and change controls associated with computerized laboratory systems.
• Participate in FAT, SAT, system implementation, and commissioning activities.
• Coordinate with QC users and vendors to define testing requirements and ensure successful validation execution.

Requirements:

• Bachelor's degree in a relevant life science field (e.g., biology, biotechnology, biochemistry). .
• Min. 5 years of relevant experience in deviation investigations within GMP environments (pharma, biotech, manufacturing).
• Excellent communication skills, both written and verbal, in English.
• Ability to multitask and work in a fast paced environment with competing priorities.
• Great team player. Strong interpersonal and communication skills and ability to develop close working relationships and work collaboratively with internal and external contacts at all levels

What's In It for You

• Exposure to the major Pharmaceutical Companies in the industry.
• Annual leave benefits.
• Full Health coverage and benefits.
• Training and Development allowance.

What's Next

If you are interested in applying for this position, please send an email to [Confidential Information].

Coalesce Management Consulting operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation, or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.