Healthcare Quality Assurance Specialist

Salary not available. View on company website.

United Parcel Service of America, Inc., Heath and Reach, Central Bedfordshire

Full time
Permanent
Onsite working

Posted 2 weeks ago, 11 Jul | Get your application in now before you miss out!

Closing date: Closing date not specified

Job ref: 74f15335dbf94523829c7eb711d65d71

Location ref: Heath and Reach, Central Bedfordshire

United Parcel Service of America, Inc.

Full Job Description

Supporting the Head of QA & RA, QA Managers, Responsible Persons and Qualified Persons with the implementation and maintenance of the Quality Management System in accordance with the GMP and GDP Guidelines and GPhC, ISO 13485 standards.
Supporting on going compliance with relevant standards, legal requirements, regulations and the PSDL documented policies and procedures.
Promote a positive quality culture within the organisation.
Supporting the Quality System Management Reviews, including the preparation of meeting inputs, attendance and presentation at meetings and the management of the meeting outputs.
Supporting Regulatory, ISO and Client audits, and conducting Supplier audits, Internal audits, and self-inspections, including the preparation of responses and CAPA plans.
Preparing draft quality technical agreements for clients and suppliers.
Supporting in the preparation and review of risk assessments for quality risk management and change requests.
Ensuring the effective control of all documentation within the Quality Management System, in line with procedures for the control of documents, physical and electronic records.
Investigation and reporting of incidents, including deviations, non-conformance's, client feedback and customer complaints, including the logging, notification, investigation, reporting, and approval of incidents.
Collaborating with the RPs to urgently and accurately perform all operations required during a pharmaceutical recall.
Reviewing and logging all MHRA product recall notifications.
Assisting with the implementation and maintenance of company training programs.
Assisting with monitoring and evaluation trends in warehouse and vehicle temperature conditions to ensure that products and orders are stored and transported in the correct conditions.

Mandatory Requirements: Candidates must have a diploma certificate or other evidence of formal qualifications awarded on completion of a university degree or other higher education course of study in Pharmacy, Chemistry, Medicine, Biology, or a related life science, or such other qualification as the licensing authority is satisfied is equivalent., Degree or Diploma certificate in Pharmacy, Chemistry, Medicine, Biology or a related life science.
Strong organisational and communication skills, with excellent attention to detail.
Ability to show initiative and be proactive, working well under pressure and prioritizing workload, with the ability to influence others.
Able to build effective working relationships with other members of the QA team, internal customers and clients, and other departments across the network.
Excellent understanding of the quality standards required and able to promote a positive quality culture within the company.
Must appreciate the need to maintain confidentiality.
Good working knowledge of Word, Outlook, Excel, Teams, and PowerPoint
Demonstrate a general understanding of company policies and procedures, pharmaceutical logistics and supply chain.
Knowledge of GDP, GMP, and GPhC regulations, ISO 9001, and ISO 13485 standards.
Performing all delegated duties assigned by the Responsible Person and Qualified Person.
Team player mentality with ability to work on own initiative
Flexibility in terms of working hours and locations for audit/training purposes

Direct job link

https://www.jobs24.co.uk/job/healthcare-quality-assurance-specialist-127100692