|Job Ref:||204640047||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Contract||Country:||United Kingdom||County/State:||Kent||City:||Kent||Address:||Post Code:||TN23||Salary:||£25000 - £32000/annum||Post Date:||08/10/2016 02:19|
Alex Tosney is currently recruiting for a Packaging Compliance Specialist to join a pharmaceutical manufacturer based in Kent. This is an excellent opportunity to join a global brand on an initial 12 month contract. |
The salary on offer for this contract position is between £25,000pa and £32,000pa.
As a Packaging Compliance Specialist you will be responsible for authoring and maintaining a wide range of packaging documentation
Further duties include:
•Requests and sourcing materials/documentation for all Packaging Component Evaluations (PCE) (e.g. MVTR, ship tests, child resistance, compatibility) and CE marking
•Assisting packaging engineers with the drafting of packaging screening protocols and assembly of source documentation for container closure confirmations (CCC) and regulatory filing (CTD) sections P7.1/2/3
•Drafting packaging component specifications for small molecule products
•Packaging Development Plans
•Key documents and templates for combination products
•Assisting with the maintenance of lab documentation, equipment calibration/maintenance logs, training tracking, and clinical pack codes
•Authoring packaging specifications
•Reviewing new regulatory documentation and packaging test methods and facilitate updates to work practice documentation with input from packaging engineers
•Monitoring the status of packaging development plans (PDP) and manage document storage
•Liaising with vendors to request packaging specification and compliance documentation (drawing, CoC, DMF, LoA),
•Assessing QA status & requesting audit (if needed) of packaging suppliers
•Scheduling, organising, and participating in key supplier visits with department members and key business partners
•Working with vendors, procurement and legal to generate Confidentiality Disclosure Agreements
As a Packaging Compliance Specialist, you will have the following qualifications, skill sets & experience:
- Degree qualified in an engineering or science discipline or equivalent
- Relevant experience working in a QA or compliance function is essential
- Experience within the pharmaceutical industry and the ability to read and interpret engineering drawings is preferred.
- Strong skills in written and oral communication are essential and the ideal candidate would also have previous experience of building relationships with external vendors.
- The individual should be proficient with Microsoft Word, Outlook, Excel, AutoCAD, Powerpoint, Acces, Sharepoint and familiar with specification and/or document management systems, and should have the ability to prioritise and handle their workload with minimal supervision
CK Engineers is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ENG37064 in all correspondence