QMS Specialist GDP

at  Corza Medical

What we offer

• We consider applicants seeking part-time employment with a minimum of 25 hours per week
• Collaboration in an international, motivated, and dedicated team that will provide the best possible support during your onboarding.
• The opportunity to work independently and responsibly, and to actively shape processes.
• A modern work environment with flexible working hours and the option to work from home.
• A gross monthly salary on a full-time basis starting from EUR 3,800.00, with a willingness to pay more depending on qualifications.
• Benefits: meal allowance, company pension plan, employee referral program, discounted gym membership, and more

As a QMS Specialist in GDP, you will play a key role in complaint management, handling investigations, reporting, and tracking KPIs. You will manage returns, GDP deviations, and support various activities like risk assessments and training development. In addition, you will assist with Pharmacovigilance (PV) tasks and work closely with production sites to ensure compliance. Your contributions will drive process improvements and enhance quality systems, while leading or participating in innovation projects.

What we value

• Customer First - We deliver extraordinary experiences.
• Accountability - We do what we say.
• Integrity - We do what is right.
• Inspired - We love what we do.
• One Global Team - We before me, always.

What you will do

• Complaint officer Biosurgery; receipt, follow-up, performance of investigation in cooperation with GDP partners or production sites, reporting, tracking, KPI reporting;
• Handling of returns and destruction
• Investigating, reporting and tracking of GDP deviations
• Provide KPI reports in area of responsibility
• Support GDP activities (changes, risk assessments etc.)
• Responsible for Training (preparation of training plans, training material for GDP, performance of trainings, user training of electronic eDMS and eQMS systems)
• Deputy Pharmacovigilance (PV)-support (for Sen. PV manager) in all PV activities: e.g. Review of PV manual, local country PV manual, weekly complaints reports, weekly MI/PQC/AE reports review and tracking, ICSR review and tracking, literature search agreement review and tracking, signal management, SDEAs)
• Support during audits and inspections by authorities
• Lead and/or participate in projects in the areas of innovation and efficiency improvement
• Support Guideline compliance
• Participation in the further development and improvement of quality processes
• Strong cooperation with production site organization in Biosurgery division

What you will need

• Completed scientific/technical education in the pharmaceutical, or pharmaceutical-related field (chemistry, biology, biotechnology).
• At least 3 years of experience in pharmaceutical QMS.
• Experience in pharmacovigilance
• Experience in medical device / combination product
• Ability to effectively collaborate with internal and external stakeholders.
• Strong attention to detail and accuracy in data management.
• High level of initiative, high quality awareness and effective communication skills.
• Excellent command of English and German (written and oral).

What we offer

• We consider applicants seeking part-time employment with a minimum of 25 hours per week
• Collaboration in an international, motivated, and dedicated team that will provide the best possible support during your onboarding.
• The opportunity to work independently and responsibly, and to actively shape processes.
• A modern work environment with flexible working hours and the option to work from home.
• A gross monthly salary on a full-time basis starting from EUR 3,800.00, with a willingness to pay more depending on qualifications.
• Benefits: meal allowance, company pension plan, employee referral program, discounted gym membership, and more.

What we value

• Customer First - We deliver extraordinary experiences.
• Accountability - We do what we say.
• Integrity - We do what is right.
• Inspired - We love what we do.
• One Global Team - We before me, always.

Join us today and Excel@Corza!