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Job Details

Drug Product Design Packaging Compliance and Documentation Specialist

Company: Regulatory Professionals
Location:
Reference: J25011
Closing Date: 05 Jan 17
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

Drug Product Design Packaging Compliance and Documentation Specialist. Contract. 12 months Sandwich, Kent. Reguatory professionals are seeking a compliance and documentation specialist to work for an esteemed and one of the most recognised companies in the pharmaceutical industry.

Requirements:

Drug Product Design Packaging Compliance and Documentation Specialist
Employment: Contract
Duration: 12 months
Rate: Very Competitive
Location: Sandwich, Kent
Reference: J25011
Regulatory professionals are seeking a compliance and documentation specialist to work for an esteemed and one of the most recognised companies in the pharmaceutical industry.
The role:
The qualified candidate will take an active role in packaging component and pack testing vendor interactions, authoring and reviewing key documentation and ensuring compliance with internal and external guidance, to support of the entire portfolio including a wide range of dosage forms (solid oral, liquid, semi-solid, parenteral). In addition the candidate will champion the culture of knowledge sharing through development and maintenance of the network Sharepoint site and Knowledge Domain.
Important elements of the role will involve the following:
The individual will be responsible for the oversight of vendor interactions
*liaising with vendors to request packaging specification and compliance documentation
*Assessing QA status & requesting audit of packaging suppliers.
*Scheduling, organising, and participating in key supplier visits with Key business partners.
*working with vendors, procurement and legal to generate Confidentiality Disclosure Agreements
The individual will also author and maintain a wide range of packaging documentation:
*Draft packaging component specifications for small molecule products
*Packaging Development Plans
*Key documents and templates for combination products
*Author packaging specifications
*requests and sourcing materials/documentation for all Packaging Component Evaluations
*Review new regulatory documentation and packaging test methods and facilitate updates to work practice documentation with input from packaging engineers.
To ensure compliance within the network the candidate will:
*Review new regulatory documentation and packaging test methods and facilitate updates to work practice documentation with input from packaging engineers.
*Monitor the status of packaging development plans (PDP) and manage document storage.
Candidate Requirements:
-BSc degree in Engineering of Science.
-PhD is highly advantageous.
-4+ years' experience in a professional office and/or laboratory environment.
-Ability to read and interpret engineering drawings is preferred.
-Be proficient with Microsoft Word, Outlook, Excel, AutoCAD, Powerpoint, Acces, Sharepoint and familiar with specification and/or document management systems
-Strong skills in written and oral communication are essential and the ideal candidate would also have previous experience of building relationships with external vendors.
-Be eligible to live and work in the UK.
This is a fantastic opportunity to be part of a prestigious pharmaceutical innovator, with the Advantage of being on a contract type employment.


Key Words: CE marking, Drug Product Design, Packaging, Compliance and Documentation Specialist,
Primary container closure system, critical secondary container closure system, Packaging Component Evaluations, Canterbury, Kent, Essex, London ,Sussex

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