Senior Quality Assurance Specialist - Pharmaceuticals

Senior Quality Assurance Specialist - Pharmaceuticals
  • £37,000 - £45,000 per Annum
  • Permanent
  • Berkshire, England, UK Berkshire UK SL2 4HL
Job Ref: J2160823
Sector: Science
Sub-sector: Pharmaceuticals
Date Added: 29 June 2021
Senior Quality Assurance Specialist (Pharmaceuticals / Healthcare) £37,000 - £45,000 + Bonus + Competitive Benefits Permanent position, Berkshire

Senior Quality Assurance Specialist (Pharmaceutical / Healthcare)

£37,000 - £45,000 + Bonus + Competitive Benefits

Permanent position, Berkshire Based

Do you have a background in Pharmaceutical Quality Assurance (GMP), with experience also working to ISO 13485 / Medical Device standards?

Would you like to work for a global Pharmaceutical / Healthcare organisation?

My client are a leading Pharmaceutical organisation based in Berkshire, researching, developing, manufacturing and marketing innovative products, aimed to target unmet medical need. They are currently looking to hire a Senior Quality Assurance Specialist, who will be responsible for ensuring compliance across daily operations and services requiring Quality Assurance (QA) and regulatory involvement, relating in particular to GMP documentation and the implementation of a new Medical Device / ISO 13485 Quality Management System.

This is an excellent opportunity to join an international pharmaceutical and healthcare organisation with a promising development pipeline, in addition to existing portfolio of on market products.

Key Responsibilities of the Senior Quality Assurance Specialist will include;

  • Maintenance of the Quality Management System (QMS) to ensure compliance to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
  • Lead the implementation of a new Medical Device Quality Management System (QMS), in line with ISO 13485.
  • Monitor and report on non-conformities, and manage change control, deviation and CAPA activities.
  • Oversee systems relating to customer complaints and associated reporting.
  • Lead internal audits, and support with external/supplier quality audits.
  • Review batch release documentation and coordinate error correction.
  • Frequent interaction with internal teams, including to support product licence and regulatory submissions.

To be considered for this Senior Quality Assurance Specialist vacancy, you will need the following skills and experience;

  • Previous demonstrable Pharmaceutical Quality Assurance experience with a good working knowledge of GMP / GDP regulations.
  • Experience working in line with ISO 13485 / Medical Device standards.
  • Experience working with Quality Management Systems (previous experience with Trackwise® QMS is advantageous).
  • BSc/MSc in a relevant scientific subject (Chemistry, Pharmaceutical Science, Biochemistry, Pharmacology, Biotechnology etc.) or equivalent relevant working experience.
  • Excellent communication skills and a personable nature, to support relationship building with internal and external cross functional teams.
  • Strong attention to detail and organisational skills, with a thorough approach.

Key Words "Senior Quality Assurance Specialist, Quality Assurance, QA, Quality Management System, QMS, Trackwise, Pharmaceutical, Biopharmaceutical, GMP, Good Manufacturing Practice, GDP, Good Distribution Practice, Medical Device, ISO 13485, Regulatory, Berkshire."

Please apply online or call Katie-May Kress on 0203 0964711 for more information

29/07/2021 14:04:13
GBP 37000.00 45000.00 Annum
Contact Consultant:
Katie-May Kress

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