QA Analyst - Ophthalmology - Hampshire

Medical Affairs, Other

South East (Excluding London)

£Competitive

Evolve Selection Logo View company profile

Reference: 6089

* This Vacancy Has Now Expired *

Looking for the next step in your career?
Evolve Selection are currently recruiting for an exciting new opportunity with a dynamic and supportive Pharmaceutical organisation. Our client specialises within the Ophthalmology market, and are now looking for a QA Analyst to join their already established team, based at the company’s head office in Hampshire. The main purpose of this role is to work alongside the Senior Quality Analyst with Quality Management Systems to help support business growth and ensuring adequacy of systems and processes to meet business needs and quality standards and regulations.

Requirements:
A background in medical devices and/or pharmaceuticals.
Minimum BSc (Hons) Degree in Sciences, Engineering, or equivalent.
Experience working with ISO 13485 2016
Ideally experience in sterile manufacturing.

Role Responsibilities:
Liaise with Notified Body, Competent Authority and QPPV regarding potential and actual reportable vigilance issues.
Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to.
Ensure that the company’s products comply and are released in line with the requirements of the Medicines and Medical Devices Regulations.
Maintain the Quality Manual, ensuring it is reflective of current practice always.
Alignment Quality Management System with scope of the company’s Healthcare certifications and with the company’s Healthcare Quality Policy.
Work to compliance standards in GDP and company logistics policy.
Ensure Good Pharmacovigilance Practice requirements and followed and met.
Advise on product development from a Quality and Compliance perspective.
Work alongside Manager to overlook the Quality Management Review Process.
Work with Managers on all internal and external audits, including hosting external audits/inspections at the company.
Work with Managers to help review CAPA management including EC Vigilance reporting.

Role Specific Competencies:
Good organisation skills.
Attention to Detail.
Ability to work under pressure.
Deadline driven.
Adaptable to changing priorities.

Recruitment Process:
2 stage process.

Package:
Above average salary + excellent bonus/benefits.

Evolve Selection is a leading UK recruitment and contract sales organisation (CSO), operating within the Pharmaceutical, Healthcare and Medical Device sectors. We offer a highly comprehensive range of permanent recruitment and flexible contract sales solutions. Please do not hesitate to get in contact with us on 0113 457 0777.

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