RPi Healthcare Quality Assurance Specialist

Before you apply to a job select your language preference from the options available at the top right of this page.

Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities experience our rewarding culture and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrowpeople with a unique combination of skill passion. If you have the qualities and drive to lead yourself or teams there are roles ready to cultivate your skills and take you to the next level.

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-conformances 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

UPS is committed to providing a workplace free of discrimination harassment and retaliation.

Required Experience:

IC

Employment Type : Full-Time
Experience: years
Vacancy: 1