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Compliance Analyst - Pharmaceuticals/Medical

Eingestellt von Elevate Direct

Gesuchte Skills: Sales, Marketing, Support

Projektbeschreibung

COMPLIANCE ANALYST/BEERSE, BELGIUM/6 MONTHS CONTRACT/30 TO 52 EUR (PER HOUR)

THE ROLE

Possess knowledge of cGMPs, regulations and risk management requirements to allow for independent triage of product quality complaints in order to execute a thorough complaint assessment in accordance with Standard Operating Procedures while utilizing the Product Quality Management System. This may include but is not limited to, review of the event reported, determination of the defect category, MDR reportability, criticality assessment, recovery of field samples for evaluation (US only), follow-up with complainant (US only), and ensuring timely communication to management when applicable.

THE COMPANY

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

RESPONSIBILITIES:

- Exhibit strong communication skills in order to collaborate with Business Partners (Internal JSC Manufacturing sites, External Business Partners, regional ESIQ organizations, Call Intake Centers, and Global Medical Safety/LSOs, Brand Protection, etc.) to ensure appropriate complaint handling.
- Deliver appropriate training to complaint management system end users.
- Works independently, challenges the status quo, identifies gaps and process improvements. Participates within special projects
- Maintain and update applicable department procedures via the Document Management System
- Process and analyze product complaints according to Policies and Standard Operating Procedures.
- Evaluate product quality complaints for seriousness, MDR reportability, correctness and consistency of categorization.
- Assign complaints to appropriate investigational sites.
- Communication of potential serious PQC's in a timely manner, as appropriate.
- Retrieval of field samples (US only), as applicable.
- Ensure all relevant complaint data is obtained.
- Partner with customers (JJQS, Internal JSC Manufacturing Sites, External Business Partners, Regional ESIQ organizations, Call Intake Centers, Global Medical Safety/LSOs, Marketing, Sales Administration, Brand Protection, etc.) to gain knowledge of products and processes.
- Participate within and monthly execution of PQC complaint monitoring to ensure standard process is followed, and data is consistent and of high quality to assist with correct decision making.
- Support internal and external audits and inspections.
- Participate within special projects.
- Deliver training for colleagues and customers on complaint handling process, product specific training, and complaint handling system updates/changes.
- Effectively communicate and collaborate with customers (JJQS, Internal JSC Manufacturing Sites, External Business Partners, Regional ESIQ organizations, Call Intake Centers, Global Medical Safety/LSOs, etc) to continuously identify and assess improvements to complaint handling processes.

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.

Projektdetails

  • Einsatzort:

    Beerse, Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Elevate Direct