Technical Assistant (1 year contract)
Posted 2 weeks ago by Grifols
Negotiable
Undetermined
Hybrid
Cambridge, England, United Kingdom
Summary: The Technical Assistant role at Grifols involves supporting the administration of the Business Management System (BMS) and associated audit programs within a global healthcare company. The position requires meticulous documentation control, participation in audits, and collaboration with various departments to ensure compliance and efficiency. The role is hybrid and offers a one-year contract, focusing on enhancing operational processes in the healthcare sector.
Key Responsibilities:
- Administration of the Business Management System (BMS) and associated audit programme.
- Control of all documentation within the Company’s management systems.
- Administration of the SOP review system and filing records.
- Perform audits as a member of the Technical Department’s auditing team.
- Plan, participate, and write up reports for BC exercises and live incidents.
- Maintenance of the internal audit timetable.
- Ensure Training Matrix and records are completed for Technical, Customer Service, and Warehouse staff.
- Organisation and tracking of SAP Fiori for deviations, CAPAs, and complaints.
- Preparation for LR and other external audits.
- Preparation of management system summaries for Management review meetings.
- Collating and writing up meeting minutes from Management Review Meetings.
- Assist with the day-to-day operation of the company’s BMS.
- Provide administrative support for the Technical Director and Technical Manager.
- Manage the sample submission programme to the NIBSC.
- Administration and organisation of the company archive system.
- General Administration Duties for the Technical Department.
Key Skills:
- IT literate with good knowledge of Microsoft Office.
- Excellent attention to detail.
- Able to work methodically and carefully.
- Strong organisational and time management skills.
- Excellent interpersonal skills.
- Internal auditing skills (desirable).
- Working knowledge of ISO 9001 and ISO 22301 (desirable).
- Knowledge of pharmacovigilance (desirable).
Salary (Rate): undetermined
City: Cambridge
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Technical Assistant (1 year contract)
What Your Responsibilities Will Be
- Administration of the Business Management System (BMS) and the associated audit programme: Control of all documentation included within the Company’s management systems including Business Continuity documents
- Administration of the SOP review system including collecting and collating all SOP acknowledgements for all new versions of SOPs which have been issued and filing records in appropriate staff members folders (All GUK)
- Administration of the Technical Area on LSQM
- Perform audits as a member of the Technical Department’s auditing team
- Plan, participate and write up reports for BC exercises and live incidents.
- Maintenance of the internal audit timetable
- Ensuring Training Matrix and records are completed and maintained for Technical, Customer Service and Warehouse staff.
- Organisation&tracking of SAP Fiori for deviation, capas and complaints
- Ensuring NCs, OFIs and CAPAs are completed in an accurate and timely manner working closely with relevant parties
- Preparation for LR and other external audits.
- Preparation of management system summaries for Management review meetings & monthly management reports.
- Collating and writing up meeting minutes from Management Review Meetings
- Preparation of monthly review meetings with Customer Services, Technical and Warehouse departments.
- Assist with the day to day operation of the company’s BMS
- Provide day-to-day administrative/secretarial support for the Technical Director and the Technical Manager:
- Manage the sample submission programme to the NIBSC, including processing quality and regulatory documentation and maintain the sample submission spreadsheets - working closely with relevant parties: Grifols manufacturing sites, NIBSC and MHRA to co-ordinate the process and ensure that batches are released efficiently according to demand.
- Administration and organisation of the company archive system
- Prepare letters and documents as required
- General Administration Duties for the Technical Department and to cover other Departments only during sickness and holidays
- Responsible for Administration of the Business Management System (BMS): Good Distribution Practices, ISO 9001 and Business Continuity Management System (ISO 22301).
- Administration of the audit program associated with the BMS.
- Provide day-to-day administrative/secretarial support for the Technical Director and the Deputy Technical Director.
- General Administration Duties
Who You Are
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required.
- IT literate, to include good knowledge of the Microsoft Office package (essential)
- Good standard of education
- Excellent aptitude for attention to detail (essential)
- Able to work methodically & carefully (essential)
- Strong organisational & time management skills (essential)
- Excellent interpersonal skills: listening, empathy, assertiveness, management, motivation) (essential)
- Internal auditing skills (desirable)
- Working knowledge of ISO 9001 and ISO 22301 (desirable)
- Knowledge of pharmacovigilance (desirable)
Location:EMEA : United Kingdom : Cambridge || Hybrid
Learn more about Grifols