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QA Scientist

Job Title: QA Scientist
Contract Type: Fixed Term
Location: Guildford, Surrey
Industry:
Salary: £28000 - £32000 per annum + company benefits
Start Date: March 2017
Reference: 68785-PHARM-JHY_1487674408
Contact Name: James Harvey
Contact Email: James.Harvey@volt.eu.com
Job Published: February 21, 2017 10:53

Job Description

Job title: QA Scientist
Job type: 9-12 month FTC
Location: Guildford, Surrey, SE England
Salary: £28,000 - £32,000 / year DOE + company benefits

Background:

- My client is a leading pharmaceutical development company with an enviable
portfolio of specialist products
- Due to continued growth they are looking to add a highly-motivated & competent
QA Scientist
- They would expect this person to be a graduate with some experience of working
in a regulatory environment

Main Purpose of Job:

- To facilitate Quality Systems and Support activities for the site GLP and GMP
activity
- Support and maintain Quality GxP / compliance and validation programmes which
comply with Global Quality, GMP and regulatory requirements

Main Responsibilities:

- Support internal audits of facilities to ensure compliance to GxP and other
applicable standards
- Implement and maintain the quality programs for the QA department including but
not limited to, document control, supplier qualification, Technical Agreement
implementation and internal/external audit program
- Review and approve of change controls, deviations, OOS, CAPAs, audit comments
and other related quality records and providing QA input into their generation
- Development, review and revision of standard operating procedures for R&D and QA
- Training and implement QA procedures for compliance with GxP
- Participate in continuous improvement activities
- Audit R&D and QC raw data where appropriate to ensure that the work has been
completed to GxP
- Liaise with Study Directors, and senior management; communicating information
and updates as appropriate
- Approve restricted document types on behalf of QA
- Ensure that all documentation, computer data and records are stored appropriately
- Approve specifications, sampling instructions, test methods and other Quality
Control procedures
- Review batch manufacturing records prior to manufacture
- Review and approve completed batch manufacturing records post-manufacture
- Review and monitor suppliers of materials
- Approve or reject, as appropriate, starting materials, packaging materials, and
intermediate, bulk and finished products
- Support the retention and archiving of records
- Monitor compliance with the requirements of Good Manufacturing Practice
- Review and compile manufacturing batch records and associated data ready for QP
batch release
- Support and review qualification and validation programmes

Qualifications, Skills & Experience Required:

- Educated to degree level in a Scientific discipline
- Experience of working in a regulatory environment within either the
Pharmaceutical or related industry
- Demonstrable commitment to Continuous Improvement
- Excellent work ethic with strong attention to detail
- Excellent communication skills with the ability to fit in to a small, specialist
team
- Ideally, some experience of working in a client / customer-facing role