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Quality Assurance Specialist

Job Description:

Job Title: Quality Assurance Specialist
Location: Berlin
Department: Quality
Work Pattern: 40 Hours per week
Reporting to: Quality Assurance Manager
Responsible for (staff): N/A

The role is to implement and execute tasks relating to day to day Quality Assurance aspects. The role entails taking responsibility for Quality Assurance matters around processes and documentation.

Essential Duties and Responsibilities:

  • Writing and reviewing SOP’s, Work Instructions and Forms.
  • QC support for Clinical operations:
    • Goods in checks
    • Goods out
    • QA support for deviations etc.
  • Coordinate and Review Deviations, Non-Conformance reports, Corrective and Preventive Action Requests and assist in the preparation of final reports for QP review.
  • Coordinate the Change Control Board, follow up on change control actions with appropriate action owners and drive for on time closure of actions.
  • Perform quarterly Environmental monitoring
  • Assist in the preparation of Product Quality Review reports.
  • Prepare Monthly Metrics.
  • Complete complaints investigations and assist with close out of complaints.
  • Responsible for executing training for quality & other relevant personnel.
  • Coordinate cGMP internal audits.
  • Coordinate and Assist in the performance of external audits (as required).
  • Assist with preparation for customer/regulatory audits.
  • Assist with audit requests during customer/regulatory audits.
  • Prepare responses to customer audits.
  • Host/attend cross departmental meetings as required as quality representation.
  • Identify and support opportunities for improving processes and or procedures.
  • To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities.

Requirements:

Regulatory/Industry Responsibilities:

General

Qualifications:

Required

  • 2-3 Years’ Experience within a quality systems related role.
  • Demonstrable experience within Quality department in a packaging or pharmaceutical company.
  • High level knowledge of packaging equipment, facilities and processes.
  • To have good knowledge of Quality Assurance inspection requirements.
  • Good working knowledge of cGMP
  • QMS Experience
  • Risk Analysis and Associated Methodology
  • Knowledge of ICH, GAMPs, Annex 11 and Eurdalex guidelines
  • Formally qualified to Degree level in an Engineering or other scientific discipline
  • Received formal training in cGMP requirements from Quality Assurance
  • Good Interpersonal skills
  • Good written communication skills
  • Good numeracy / literacy
  • Good team skills
  • Technical aptitude
  • Strong commitment to Quality Assurance principles
  • Analytical approach / attention to detail
  • Professional
  • Self-motivated and organised
  • Persuasive

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