Connecting to LinkedIn...

Director QA Technical Support Lead

Job Title: Director QA Technical Support Lead
Contract Type: Contract
Location: Dublin
Industry:
REF: 122404
Job Published: about 1 year ago

Job Description

Director QA Technical Support Lead, EU
To provide QA and technical support to External Suppliers and internal stakeholders in order to ensure commercial products are manufactured

Responsibilities
To provide support to the EU QA Technical Team in support of the GMP compliant validation and process control of the manufacturing processes (including packaging and testing where appropriate) for drug products and drug substances manufactured at third party contractors in the International region.
The scope of activities of the EU QA Technical Support Team includes the approval of protocols and reports, review of batch documents, investigation of quality issues, and the development and maintenance of effective working relationships with all contractors drug products and drug substances, specifically in relation to the following activities:

- Validation / Revalidation activities
- Technology transfers
- Process improvements
- Product Characterisations
- Scale-up
- New Product Introductions

To manage the following projects:
? Project Lead for EU GMP Chapter 5 Cross Contamination Controls including compliance of outsourced operations (commercial and clinical products) globally. Provide updated reports monthly to the governance meetings.
? Quality representative for the Data Integrity project. This may involve review of guidelines, participation in team meetings to draft policy document and /or functional gap assessments.
? QA Contact point for projects (product specific) included in goals 2016
? To manage the following in support of the Quality oversight of third party contractors for drug product located in the International regions.

The scope of activities includes the following to ensure the GMP compliant supply of drug products and drug substances:

? Performance of CMOs and audit follow up actions
? Support of complaint investigations
? Support of product recall activities
? Performance of GMP audits,
? Quality improvement programmes,
? Quality Technical Agreement preparation and maintenance
? Supplier performance monitoring activities

Education and Experience Requirements
? University degree or equivalent qualification in Life Science subject
? Significant period of practical experience in the Pharmaceutical Industry, a majority of which has been gained in a QA environment, and including manufacturing
? Experience of working with contractors
? Good working knowledge of EU global GMP requirements for solid dosage forms

Key Skills, Abilities, and Competencies
Excellent interpersonal and communication skills
Able to work with many organizations / cultures / quality systems
Ability to understand and write technical reports
Ability to contribute significantly to the continuous improvement of business practices
Demonstrated ability in strategic thinking, acting and influencing skills
Business acumen
Expected to act on own when complex issues arise and provide/prepare solutions which maintain Quality Standards and consider business requirements
Expected to work with a multiple of contractors / products on a global basis
Uses experience to facilitate troubleshooting, and to tackle non-routine work and projects independently and ensure continuity of compliant supply
Create innovative solutions and drives improvements and rationalizations to systems, policies and procedures
International travel required to visit contractors and other sites.

For further information on this Director QA Technical Support Lead, EU position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
Follow us on Facebook, Linked-in, twitter