Compliance Assurance Lead for Global Life Sciences
vor 1 Monat
We are seeking a Compliance Assurance Lead for our Global Life Sciences team to join Planet Pharma in Germany. This role offers an exciting opportunity to lead the supplier qualification process and manage initiatives to complete requirements audits.
About the Role:
- Leverage expertise in GMP Auditing to lead the supplier qualification process and manage initiatives to complete requirements audits, including on-site supplier audits.
- Collaborate with the QA department to perform and process supplier quality requirements audits and supplier reassessments.
- Develop audit evaluation strategies and logistics, identifying weaknesses, ineffective procedures, policy exceptions, and discrepancies, and recommend appropriate corrective actions.
- Evaluate supplier responses to corrective and preventive actions related to audit findings.
- Assist in the review of supplier requirements by obtaining quality requirements and solutions for areas identified as compliance issues.
- Provide subject matter expertise during customer audits, internal audits, and/or regulatory inspections.
Requirements:
- GMP Auditing experience.
- Experience in the pharmaceutical, medical device, combination product, and/or biologics industry desirable.
- Experience in auditing production facilities and laboratories.
- IT skills in Microsoft Office and eQMS software (TrackWise, JDE, Veeva, etc.).
- Knowledge of pharmaceutical regulations and international standards for aseptic manufacturing as well as project management skills.
- Ability to work in a team, strong interpersonal skills, and excellent communication skills in German and English.
What We Offer:
- An estimated salary of €80,000 - €110,000 per annum, depending on experience.
- A competitive benefits package.
About Us:
Planet Pharma is a global life sciences company that values innovation and collaboration. We strive to deliver high-quality products and services while maintaining the highest standards of compliance and regulatory excellence.
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