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Multiple Data Integrity Consultants Needed

  • Location: France
  • Salary: Negotiable per hour
  • Job Type:Contract

Posted 25 days ago

  • Sector: Life Sciences
  • Contact: Robin Hussain
  • Duration: 9 months
  • Start Date: 22/11/2021
  • Expiry Date: 05 December 2021
  • Job Ref: JN -112021-465363

Multiple Data Integrity Consultants Needed - ASAP Start - Drug Product Manufacturing Experience

Multiple positions available for one of our clients in France. Working from Normandy, France with minimal remote work (3-4 weeks on-site, 1 week off, etc.) with Drug Product manufacturing experience (filling, label and packaging, visual inspection), start date Nov 22 or 29:

    1. 1 x Data integrity "leader" to manage and lead the execution of DI work. 6 months. Director level
    2. 2 x data integrity execution experts to initiate gap remediation and close gaps. 6 months Manager / director level. Experts with data integrity remediation, experience doing this work
    3. 2 x QA/MFG Investigators. 9 Months Manager / Director level. Writes deviations, trains staff, excellent English and French writing skills. Knows investigations procedures, experience writing investigation
    4. 5 x Manager / director level consultants for change control and CAPA. 9 Months. Experience writing and closing CAPA and CCR records. Train staff on Change Control Requests and CAPA. CCR and CAPA experts. Assess procedures, revise them, get revised procedures in the system and effective
    5. 1 x Senior Project Manager for 1 year to manage the sites quality remediation. French and English speaking. Knows US regs. Experience establishing KPIs and report out status to core team and steering committee. Must have experience leading large quality system remediations (like consent decrees). Scope of remediation includes inspection readiness, quality Maturity index, backlog reduction, data integrity, annex 1, Quality culture
    6. 6 x director level consultants for 6 months to oversee the packaging line clearance process. Assess current procedures, provide independent line clearances and process confirmations, oversee and execute the line clearance process, provide coaching and training to staff. Experience in this area of production label and packaging, perfect candidate would have had responsibility leading this operation in their experience.
    7. 4 x director level consultants for 6 months to review Batch records. Assess current procedures, Provide independent batch record review, oversee and execute batch record reviews, provide coaching and training to staff. Experience in this area of production label and packaging, perfect candidate would have had responsibility leading this operation in their experience
    8. 3 x consultants for 6 months to act as Data integrity "coaches". Expert in data integrity, on the floor helping to change practices, provide coaching and mentoring to staff. Experience in production label and packaging, works with staff, on the floor

If you fit any of the roles or know anyone that fits the role then please send an email to danielhay@hydrogengroup.com with a CV attached

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