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Senior QA Specialist

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Achieva Group Ltd

2021-12-03 07:36:46

Job location Barkingside, Greater London, United Kingdom

Job type: fulltime

Job industry: Other

Job description

Achieva currently have an opportunity for a Regulatory Affairs Officer to join a medium-sized Pharmaceutical company.

*The role: *
To conduct, coordinate and support quality aspects of the business operation, ensuring quality compliance throughout the business with focus on WDA, MIA and GMP and GDP activities. Support RPi release of products to UK market.

*Skills and Qualification: *

* BSc Pharmaceutical Studies
* Over 3-5 years' experience within the pharmaceutical and medical devices' industry.
* Experience hosting both internal and external auditing (MHRA, EU GMP, EU GPD, ISO13485, US FDA).
* Experience with risk assessment, managing deviations and CAPAs, validation control, SOPs, and batch reviews.
* Implementing and maintaining eQMS.
* Setting and managing KPI's.
* Experience developing training programs, and training on eQMS.

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