Research Quality Association

Quality Assurance Manager

DS Biopharma Limited
Oxford, South West England, United Kingdom
14 days ago

Description

Quality Assurance Manager - UK & Ireland

Main Duties / Responsibilities:

  • Maintain and develop the Quality Management System (QMS) in accordance with relevant regulatory requirements and business need
  • Implement an effective Quality Assurance process, including internal and external audit programs, and ensure timely completion of audits
  • Lead the quality oversight process on outsourced activities, which includes;

o Developing and maintaining Technical Agreements with vendors in line with relevant regulatory and business requirements
o Performance of onsite audits as required – vendors / clinical sites
o Analysis and reporting of Key Performance Indicators (KPIs)

  • Oversee the effective documentation and tracking of QMS activities, including deviations and change controls, and the implementation of corrective actions.
  • Provide quality leadership and support to operational teams, including the review of batch records, technical reports and clinical trial protocols
  • Manage the Documentation Control process, ensuring that policies and procedures are up to date, and available to all relevant parties
  • Ensure that all activities are conducted in compliance with the requirements of Good Manufacturing Practice and Good Clinical Practice.
  • Contribute to Company Training procedures as required
  • Carry out various other additional tasks that may be required from time to time in accordance with the overall goals of the company

Requirements:
1) Scientific degree
2) At least 3 years GCP and GMP experience in the pharmaceutical industry
3) QA auditing experience
4) Knowledge of relevant regulatory requirements
5) Excellent interpersonal, communication, and problem solving skills
6) Strong computer skills
7) Flexible in reacting to changing priorities in a dynamic business environment.
8) Ability to travel as required

Reference ID: Quality Assurance Manager - UK & Ireland

Job Types: Full-time, Permanent

Salary: £50,000.00-£60,000.00 per year

Additional pay:

  • Performance bonus
  • Retention bonus

Benefits:

  • Company events
  • Company pension
  • Private medical insurance
  • Profit sharing
  • Work from home

Schedule:

  • Monday to Friday

Experience:

  • Quality Assurance: 1 year (preferred)

Work remotely:

  • Yes

COVID-19 precaution(s):

  • Remote interview process
  • Temperature screenings
  • Social distancing guidelines in place
  • Virtual meetings
  • Sanitisation, disinfection or cleaning procedures in place


Job Information

  • Job ID: 57269650
  • Location:
    Oxford, South West England, United Kingdom
  • Position Title: Quality Assurance Manager
  • Company Name: DS Biopharma Limited
  • Job Function: Quality Assurance
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