QC Analytical Validation Specialist

4 weeks ago

Haverhill, United Kingdom EUROAPI Full time

Join our global quality team where you will be responsible for providing active ingredients that meet the highest pharmaceutical regulatory and compliance standards.

This opportunity is for a QC Analytical Validation Specialist to join the QC Technical Services Team on a contract basis. The duration of the contract will be 23 months.

Your Responsibilities

You will: 

Owns analytical projects and deputizes for leadership, working with R&D, clients and key stakeholders. Works with QC management team to assign and manage project resourcing. Sample, analyse and release API, drug products, test incoming raw materials and drug packaging, provide import testing for drug product batches, CDMO batch testing, In process samples, cleaning validation, verification analysis and batch release for raw materials. Write, review, and drive the completion of validation/analytical transfer activities, owning your analytical projects within the team and sharing best practice within the group. Develop, train and report validation and transfer activities within QC for new and existing clients. Lead effective reactive and proactive investigations, driving continuous improvements. Drive compliance working with QA and promote quality standards. Research, develop, train and report validation and transfer activities within QC for new and existing clients. Ensure effective troubleshooting of equipment or technique failures and troubleshooting of problems associated with various analytical techniques. Sample, analyse, and release drug products, test incoming raw materials and drug packaging, provide import testing for drug product batches, CDMO batch testing, cleaning validation, verification analysis and batch release for raw materials. Write, review, and drive the completion of validation/analytical transfer activities, owning your analytical projects within the team.

Our Company

EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies, while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.

Taking action for health by enabling access to essential therapies inspires our 3,450 people every day. With strong research and development capabilities and six manufacturing sites all located in Europe (Saint-Aubin-lès-Elbeuf and Vertolaye in France, Brindisi in Italy, Frankfurt in Germany, Budapest in Hungary and Haverhill in the UK), EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries.

EUROAPI is listed on Euronext Paris.

The EUROAPI Haverhill (UK) site has been established for forty years, located fifteen miles east of Cambridge and sixty miles north of London, within the golden triangle. It employs over 250 people and has built a strong reputation in Flow Chemistry, Active Pharmaceutical Ingredient (API) Spray Drying and as a Contract Development and Manufacturing Organisation (CDMO). Haverhill is proud to house the world’s largest, continuous production, pharmaceutical spray dryer and performs secondary packaging and release activities for oncology and rare disease medicines supporting global markets. The site also offers a contract testing and release facility within its laboratories.

Our Requirements

Sciences degree.

A high level of pharmaceutical experience handling HPLC, GC, FTIR, UV, PXRD, DSC.

GMP knowledge coupled with proven experience of analytical method validation & transfer principles.

Experience of deputizing for senior leadership and working closely with R&D, clients and key stakeholders to manage key analytical projects.

What we offer

Competitive hourly rate and retention bonus Training & development A quick turnaround with two interviews (teams interview and face to face) and flexibility to offer a quick start date 23 months contract term 36 hours per week, Monday-Thursday 9-5.30pm, Friday 9-4pm

Apply Today

Find out more about this exciting opportunity, apply today or contact Victoria Barry-Woods.

Do you know someone for this role?

We are accountable for the success of EUROAPI and that means finding the best people that share our values. Refer a candidate today or talk to your HR Business Partner to find out more.

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