Pharma Compliance Consultant - Germany
Want to know company name or location? Company managed [?]
- Our company is a service provider company, leader in Pharmaceutical and Medical Device sectors since 1998.
- With a network of over 200 dedicated consultants, our company delivers the highest level of expertise to more than 160 customers worldwide.
- An international group, our company operates in over forty countries throughout Europe, Asia and the Americas.
- Our company offers a worldwide coverage with offices and representatives across Europe, Asia, the Middle East and Latin America, in order to better serve these specific local markets.
In this full-time role, the person will be responsible to work in different projects related to Pharma Quality Compliance such as authority inspection preparation and/or remediation or quality improvement initiatives.
The person will work alone or more frequently among multidisciplinary teams and he/she will be coordinated by appropriate senior roles.
MAIN AREA OF EXPERTISE:
- API manufacturing (including high potent compounds;
- Finished Product manufacturing;
- Sterile productions (both APIs and FPs);
- Excipient manufacturing
- Pharma distribution (APIs and FPs)
- Technical Degree (Pharmacy, Pharmaceutical Chemistry, Microbiology, Chemistry, Engineering)
- Minimum of 3 years’ experience in the Pharmaceutical industry (covering managerial or key roles)
- Basic knowledge on the main rules/guidelines/best practices of the major regulated markets (EU and US)
- Suppliers/Vendor management (e.g.: qualification audits, monitoring etc)
- Basic knowledge on Quality Risk Management and Continuous Improvement
- Basic expertise on analytics and QC Labs processes
- Experience in the preparation and hosting of Authority inspections (nice to have)
- Operational Excellence skills / Lean-Six Sigma certifications (nice to have)
- Project management (nice to have)
- Time management (nice to have)
- Customer management (nice to have)
- English (fluent): mandatory
- German (native): mandatory
- French: nice to have
- Spanish: nice to have