An outstanding opportunity to gain valuable insight into Quality Management and Regulatory activities within a market leading organisation based in Hull
Support QA activities associated with our clients Regulatory Excellence programme. All change controls, master documentation and training requirements as outputs of specified projects are actively maintained. Support the capture of and facilitation of Process Maps alongside chosen consultants, ensure maps are captured and authorised in our clients chosen system.
Keep a Master List of controlled documents and assign new unique numbers for documents.
Ensure that the drafts, working and final copies of SOPs, Technical agreements and other QA controlled documents are organised into electronic files and are easily retrievable when required and that these files have restricted access.
Manage the periodic review process review for quality documents such as policies, SOPs and other controlled documents.
Become the electronic documentation management system (TDS) expert for our clients.
Ensuring that documents and loaded into the correct area and maintain the continued compliance status for the system and become SMART site administrator and expert^for QA and Regulatory (When support is required)
You will also be able to support management and administration of the Cross Functional Change Control Process. Plan meetings, take minutes, chase actions, update CFCC tracker and extract and interpret KPIs. Ensure all documentation is up to date and filed appropriately.
Essential Skills & Qualifications
Good organisation and planning skills
Good communication skills
A proven track record and relevant experience of working in a document^control department within Healthcare, Pharmaceutical, or Medical Device related industry
Basic understanding of typical regulatory requirements relevant to a regulated product e.g. EU GMP, CFR 21 Part 210/211, would be desirable
Auditing skills and^appropriate qualifications in auditing is an advantage for this role.
Working Language(s): English
Flexible Working Hours: No
Employer: Pharmaceutical Company
Employment Type: Permanent
Hours: Full time
Location: UK, NE
Plan Start Date: , Please do not apply if you are unable to meet this start date.
Company Pension,life Insurance,
Registration, Regulatory Affairs, MAA, CMC, Expert Reports, Clinical Trial Applications, CTA, CPMP, Dossier, Regulatory Agency, Documentum
Assigned Consultant:Sue Spice at CSL Recruitment on 02392 556 099 or 01932 219326
Please feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs; applicants will only receive feedback if they demonstrate the skills the role requires in their application. The role may be remarketed; if you applied for this role previously and were unsuccessful you will not receive a response. We request that non EU Nationals include evidence of right to work in the country concerned with their application to be considered. Do supply supplementary information on required location, notice period and expected salary/day rate if you are a new candidate.