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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 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.
Specialized Knowledge and Requirements:
- 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
Please note for successful candidates, Polar Speed UPS will run a standard DBS check and minimum 3 year referencing checks.
Employee Type:
Permanent
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