UPS
Healthcare Quality Assurance Specialist
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Job Description
Job Location: Polar Speed UPS, Birmingham Hub, Unit 10 The Hub, Nobel Way, Birmingham, B6 7EU
Work Schedule: Monday to Friday - 40 hours per week
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.
Job Purpose and Key Responsibilities:
- 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 ongoing compliance with relevant standards, legal requirements, regulations, and the PSDL documented policies and procedures.
- Promoting a positive quality culture within the organization.
- Supporting 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.
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Specialized Knowledge and Requirements:
- Degree or Diploma certificate in Pharmacy, Chemistry, Medicine, Biology, or a related life science.
- Strong organizational 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.
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Please note for successful candidates, Polar Speed UPS will run a standard DBS check and minimum 3-year referencing checks.
Employee Type: Permanent
Company Overview: UPS is committed to providing a workplace free of discrimination, harassment, and retaliation. In 1907, two teenage entrepreneurs in a Seattle basement started with a $100 loan and created what would become the world’s largest package delivery service. Today, operating in more than 220 countries and territories, UPS is committed to moving our world forward by delivering what matters. UPS and its more than 500,000 UPSers around the globe are a transportation and logistics leader, offering innovative solutions to customers, big and small. UPS understands and appreciates its responsibility to help build safe, stronger, and more resilient communities founded on justice and economic opportunity for all, supported by a healthy, sustainable global environment.
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