SEC Recruitment: CONTRACT QA Validation Engineer


Contract QA Validation Engineer
Location: Republic of Ireland
Duration: 12 Months+
€ / hour dependent on experience

Job Summary:

One of the world's leading pharmaceutical companies is looking for a Quality Assurance (QA) Validation Engineer, on a contract basis, to act as a specialist in support of a start-up facility, ensuring full compliance and approval of operations, prior to commencing manufacturing operations. This is an excellent opportunity to gain valuable experience in the start-up operations of a manufacturing facility.

Accountabilities/Responsibilities:

Review and approve validation protocols and reports to ensure full compliance with local and EU/FDA regulations; including URS, facility, process, cleaning and equipment.
Develop, implement and maintain/revise site Validation plans
Provide training and guidance to onsite project and manufacturing teams on validation strategy
Produce SOP's and other applicable documentation
Work to industry regulations; including FDA 21 CFR

Essential Skills & Experience:

Degree in relevant scientific or engineering discipline
Solid project experience in QA and validation activities within Biotech environments
Strong industrial experience in validation functions, including equipment, facility and CSV/GAMP (21 CFR Part 11)
Experience in coordination of Qualification/Validation documentation and electronic document management systems
Strong communication and problem solving skills
Experience in start-up operations would be advantageous

You MUST be eligible to work in the Republic of Ireland

For further details or a confidential conversation please contact me directly:

Andrew Harrison
Pharmaceutical Consultant
Manufacturing - Production/Engineering
Tel: +44 (0) 207 255 6665
Fax: +44 (0) 207 255 6656
andrew.harrison@secpharma.com
http://uk.linkedin.com/in/andrewjharrison

Key words:

contract, validation, validation engineer, qualification, validation master plan, vms, quality, quality assurance pharmaceutical, pharma, biotech, biopharma, biopharmaceutical, medical devices, med devices, cgmp, gmp, good manufacturing practice, fda, cfr, 21 cfr, 21 cfr part 11, csv, computer system validation, gamp, good automation practice, equipment validation, facility validation, process validation, cleaning validation, start-up, start up, manufacturing, production, republic of Ireland, roi, Ireland

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