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Job Details

Quality System Engineer (m/f)

Company: CROMSOURCE
Location: Germany
Reference: HQ00001484
Closing Date: 09 Jan 19
Type: Temporary
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

: Norderstedt, Germany   TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Quality Engineer to strengthen the team of one of our TOP Pharmaceutical client Companies in Norderstedt, Germany.     Drive the execution of Quality Systems (QS) at site level, including non-conformities (NC) and Corrective and Preventive Actions (CAPA), Internal Audit (IA) Observations, Site Complaint...

Requirements:

Location: Norderstedt, Germany

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Quality Engineer to strengthen the team of one of our TOP Pharmaceutical client Companies in Norderstedt, Germany.

Drive the execution of Quality Systems (QS) at site level, including non-conformities (NC) and Corrective and Preventive Actions (CAPA), Internal Audit (IA) Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, Quality Progress Review (QPR) and Quality System Management Review (QSMR) to ensure systems meet all business and regulatory requirements. Manage the performance and communication of QS metrics at site level. Support site readiness in the deployment of these QS initiatives. Support compliance and continuous improvement of the Quality System. Support document control area where needed.

Main Job Tasks and Responsibilities

  • Ensures consistent and correct execution of QS procedures at the site to maintain the quality and compliance of processes and records for NC, CAPA, IA Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, QPR and QSMR. This includes:
  • Review site CAPAs, NCs, IA Observations, Site Complaint Manufacturing Investigations, QPR and QSMR documentation
  • Provide guidance on requirements
  • Assist with the development and documentation of problem statements, bounding, containment, risk assessments, investigation, and action plan determination (corrections, corrective actions, preventive actions, and effectiveness monitoring)
  • Ensure effective completion of activities
  • Ensure timely escalation of product quality and compliance issues to the proper source (NC, CAPA, Product Quality Escalation)
  • Execute CAPAs, NCs, and IA Observations related to site-specific QS
  • Develops competency of resources at the site that execute CAPA, NC, IA Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, QPR and QSMR by providing training and guidance on the execution and documentation of these processes,
  • Drives timely and compliant execution of site NCs, CAPAs, IA Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, QPR and QSMR by driving cross-collaboration across functions, monitoring progress, and elevating issues in a timely manner for resolution,
  • Supports on site the timely collection, escalation and reporting of Quality System metrics to management. This includes:
  • Provide management tracking reports for NC, CAPA, IA Observation, and Site Manufacturing Complaint Investigations
  • Submit NC, CAPA, IA Observation, and Site Manufacturing Complaint Investigation metrics for QPR and QSMR
  • Performs administrative activities for NCs, CAPAs, IA Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, QPR and QSMR. This includes:
  • Coordinate activities related to CAPA Review Board (CRB) and facilitate forums for review of progress of NCs, IA Observations and Site Complaint Manufacturing Investigations (i.e. agenda, scheduling, documentation of minutes, tracking of activities)
  • Support on-site QPR and QSMR, including coordination, preparation, execution, and tracking of activities,
  • Support Product Quality Escalations for nonconformances or issues originating at the site, including the initiation, escalation, coordination, tracking, and closure of activities
  • Support the initiation of CAPAs
  • Serve as site administrator for EtQ and Cognos
  • Supports the maintenance of original documentation for site NC, CAPA, IA Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, QPR and QSMR as quality records, and maintains meeting mintues for official review boards, where required.
  • Identifies site needs to meet and improve system performance of NC, CAPA, IA Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, QPR and QSMR at the site level, and escalates to appropriate representative and management in a timely manner,
  • Supports the deployment (design, implementation, and post-monitoring) of CAPA, IA Observations, Product Quality Escalation, Site Complaint Manufacturing Investigation, QPR and QSMR process initiatives impacting the site that promote the continuous improvement of the QS and ensure continuity of the application of globally shared processes and systems at site level,
  • Supports compliance activities by participating in audit readiness; assisting in Internal and External audits; serving as Subject Matter Expert for NC, CAPA, IA Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, Document Control, QPR and QSMR process during audits; supporting the investigation, response, and remediation of site-specific QS audit observations
  • Manage on site Document Control (as required), including management

Education and Experience

  • University degree in Medical Engineering, Biomedical Engineering, Process Engineering or comparable degree
  • First experience in quality management of a medical technology company
  • Knowledge of relevant QM systems and regulatory requirements
  • Experience in the application of quality tools, such as FMEA, 8D report
  • Good statistics
  • Independent and solution-oriented way of working
  • Strong communication and organizational skills
  • Safe appearance and assertiveness
  • High commitment and proactive behavior
  • Very good knowledge of spoken and written English

If you have the experience needed for this position, please apply @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001484

Why TalentSource Life Sciences/CROMSOURCE?

CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.

To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.

Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.

Quality Assurance Specialist, Quality Engineer, System Support Engineer

Apply for this job: Quality System Engineer (m/f)

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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