Qms Specialist Gdp

**Vacancy Name**

QMS Specialist GDP

**Location of Work**

Linz, Austria

**Employment Type**

Full Time Employee

**Our mission**
At Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between performance, value, and a quality customer experience. We are here to support you every step of the way.

**Our brand promise**
We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.
- **Remarkable service**
A seamless, personal process designed around you and your needs.
- ** Trusted performance**
Our product family is the result of years of experience championing surgeons and listening to their expertise.
- ** Outstanding value**
No matter the surgical specialty, we deliver quality products for all markets.

**Our people promise**
Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.

**Job Purpose Summary**
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.

**Corza Medical is an equal opportunity employer. Corza Medical eval