We are one of the leading European contract manufacturers in the pharmaceutical, biotech and healthcare sectors, with some 2,500 employees in Germany, France, Finland, Norway and the UK. 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.
Key Responsibilities:
Support to the site QMS including routine review and approval of change controls, deviations, action plans and CAPA. Review and approval of SOPs. Review, approval and issue of manufacturing and analytical documentation. Participation in root cause analysis investigations arising from deviations. Support both internal and external audits including writing reports, agreeing follow up actions and tracking these to closure. Participation in desk-based audits in support of the supplier assessment program as required. Support the management of supplier complaints. Review and approval of risk assessments and validation documentation as required. Support annual Product Quality Reviews as required. Provide input to and support continuous improvement initiatives.
What are we looking for in applicants?
Experience of working in a similar Quality role within a GMP environment, ideally within a manufacturing or testing facility. Experience of document review and approval. Audit experience (internal and supplier auditing). Able to communicate effectively with people at all levels in a Company. Able to write clear, concise reports.
Minimum Qualifications:
A degree or equivalent in Chemistry, Pharmacy, Biology or general science. A knowledge of MasterControl or similar quality management system. A knowledge of SAP or other ERP system.
Computer Skills:
Must be competent in the use of MS Office, particularly Excel and Word, outlook and internet.
Literacy And Numeracy:
Must be competent in generating documents and writing reports both for internal use and for customers/clients. Must be numerate. A knowledge of MasterControl QMS software would be advantageous.
Business Presentation Skills:
Must be able to give clear oral presentations.
Other Requirements:
Must have authorisation to work in the UK.
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.
Remuneration Package:
Basic Salary: £DOE Private Medical Insurance Health Cash Plan Contributory pension scheme Life Insurance
#J-18808-Ljbffr
Key Responsibilities:
Support to the site QMS including routine review and approval of change controls, deviations, action plans and CAPA. Review and approval of SOPs. Review, approval and issue of manufacturing and analytical documentation. Participation in root cause analysis investigations arising from deviations. Support both internal and external audits including writing reports, agreeing follow up actions and tracking these to closure. Participation in desk-based audits in support of the supplier assessment program as required. Support the management of supplier complaints. Review and approval of risk assessments and validation documentation as required. Support annual Product Quality Reviews as required. Provide input to and support continuous improvement initiatives.
What are we looking for in applicants?
Experience of working in a similar Quality role within a GMP environment, ideally within a manufacturing or testing facility. Experience of document review and approval. Audit experience (internal and supplier auditing). Able to communicate effectively with people at all levels in a Company. Able to write clear, concise reports.
Minimum Qualifications:
A degree or equivalent in Chemistry, Pharmacy, Biology or general science. A knowledge of MasterControl or similar quality management system. A knowledge of SAP or other ERP system.
Computer Skills:
Must be competent in the use of MS Office, particularly Excel and Word, outlook and internet.
Literacy And Numeracy:
Must be competent in generating documents and writing reports both for internal use and for customers/clients. Must be numerate. A knowledge of MasterControl QMS software would be advantageous.
Business Presentation Skills:
Must be able to give clear oral presentations.
Other Requirements:
Must have authorisation to work in the UK.
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.
Remuneration Package:
Basic Salary: £DOE Private Medical Insurance Health Cash Plan Contributory pension scheme Life Insurance
#J-18808-Ljbffr
