Assembly Specialist (process)

Role profile:

Working within the Finished Production part of the business, this role in integral to ensuring the smooth running of quality and compliance metrics, and to meet stringent regulations, working towards continuous improvement

Duties and responsibilities:

Playing an active part in the launch of a new line for finished pharmaceutical products
Verification of routine operational activities including machine start-up, adjustments, change-overs and troubleshooting equipment
Preparation of validation, qualification and inspection protocols such as IQ, PQ, OO
Document the verification activities, compile electronically and review of approvals in a timely manner
Create SOPs, CRs, carry out deviation investigations and CAPA closures
Training of assembly operators, and keep training records up to date
Careful maintenance of the machines, reporting any issues immediately and reducing cases of accidents
Process optimisation, waste and time reduction, enhancement of the line output
Following GMP and SFDA guidelines, data integrity (ALCOA) and safety procedures as outlined in the SOPs
Take an active role in audits, both internal and external

Your background:

Engineering degree
4-5 years industry experience including maintaining production equipment, compliance to authority requirements and GMP (pharma)
You must bring a pharmaceutical technology background and demonstrate you have handled complex technical processes including validation and troubleshooting equipment
Excellent written and verbal English communication skills
Collaborative, professional and solutions-focussed approach
Intercultural sensitivity, innovative and entrepreneurial in spirit

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy