Current vacancy from WÖRWAG Pharma GmbH & Co.KG

Specialist (f/m/x) Quality Systems GCP

GCP, Audit, Global Quality Department, GMP
Pharmacy
Professional, Senior, Specialist
Full-Time
ASAP
Permanent
You are experienced in the field of GxP & would you like to contribute your expertise in an agile environment? In this position you will be responsible for audits in the GCP field & support the quality of WÖRWAG Pharma's products. Look forward to a flexible & familiar environment with high development opportunities & benefit from an exceptionally broad range of tasks. Profit from an attractive salaray, flexible working hours & the possibility of working from home in a future proof family run company.
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Company This is your employer:

Wörwag Pharma GmbH & Co. KG
Family-run Mid-sized business
1.200
Pharmaceuticals & Medical Technology
22 international offices in Asia, Europe & South America Annual sales (2020) of €235.8 million Family-run International diversity (also at headquarters) with regional roots Design opportunities Growth The courage to try new things Dynamic & yet reliable

Compensation This is what you earn:

Experience- & qualification-based From 70.000 to 90.000 Euro Gross Per Year Realistic assessment during the initial interview Test your qualifications here
Payout in 13 monthly salaries
Added Value Amount
30 days / year
Compensated by free time
Numerous additional remunerations e.g. Mobile working Company pension plan Job-ticket for public transport Attractive models of salary conversion Paternity leave Meal allowance Aid for birth / wedding / anniversaries Medical officer Dealer discounts Assistance in finding accommodation Health Days Wide range of offers for personal & professional development Direct insurance allowance Flexible trust-based working hours Discounts on over-the-counter (OTC) pharmacy items Supporting offers for your general well-being or For the compatibility of family & career

Colleagues This is your team:

10-15 direct colleagues
Diverse / From young to old
Nationwide International
English German
Flat hierarchies Reporting to > Team lead

Tasks These are your responsibilities:

Tasks
Successful participation in the Global Clinical Research (G_MA_CR) & Global Pharmacovigilance (G_MA_PV) departments First contact for audits in the GCP area
Implementation of internal & external audits As part of the risk-based audit program for the G_MA_CR & G_MA_PV area Provide GxP compliant advice & guidance to Global Clinical Research teams: External study execution (e.g. hospitals, clinical research organizations) Provide GxP compliant advice & guidance to Global Pharmacovigilance teams: Internal consulting at the sites Participation in risk assessments for clinical trials as well as Derivation of suitable measures Support for development, improvement & training of GxP relevant processes & specification documents for the Global Clinical Research & Global Pharmacovigilance team Responsibility of planning, tracking & effectiveness control of corrective & preventive actions (CAPA) and Coordination of deviations In addition: Contribute to the creation of global & local process descriptions (including global & national SOPs as well as work instructions)
MS Office Amplexor O365 SharePoint SuccessFactors-Learning
Responsibility
Colleagues Employees of other teams One / few superiors Global Quality Unit Interface with: Global Clinical Research Global Pharmacovigilance Clinical studies Externals Suppliers & service providers
None
None
None

Location Your Surrounding:

Böblingen near Stuttgart and Remote work
Easy access with public transport Accessibility: Subway / Underground station Motorway connection Sufficient parking (free)
Numerous shops for everyday needs e.g Supermarket Diners / fast food restaurants Discounted canteen
High comfort Modern equipment Bright rooms Modern office building New building Open-space office
Individual materials available on request Additional screen(s) Modern office equipment Laptop
Flat hierarchies Direct / extensive communication Positive working atmosphere Collegial cohesion Feedback culture Christmas party Sports activities Annual kick-off party International Hands-on mentality
Kitchen Free coffee / tea Shower(s) Refrigerator Microwave Fruit basket

Process This is your everyday life:

Flexibel
40 hours / week
Monday - Friday No weekend shifts
Flexible
Business Casual
By arrangement Up to 2 days / week
Regularly 20% travel activity Mostly DACH-region (Germany, Austria & Switzerland) Rarely international

Perspectives These are your chances:

Individually customizable Internal & external training Any time in consultation with management As needed
Variety of career / promotion opportunities Performance-related Annual salary reviews
Future-oriented area of responsibility Permanent contract Crisis-proof position Growing & persistent industry Independent adoption of development of new processes

Qualification This is what you should bring:

Experience
Minimum 3 years of professional experience In GCP in the pharmaceutical industry Advantageous: Additional qualification as auditor (f/m/x)
e.g. Auditor Pharmaconvigilance manager Pharmaconvigilance specialist Study representative (f/m/x)
Pharmaceuticals & Medical Technology
Skills
Required: Knowledge in the use of relevant pharmaceutical IT systems (DocuBridge, Amplexor, Trackwise) User knowledge with MS Office Confident & professional communication skills Knowledge of the relevant regulations in the field of GCP
Teamwork Self-confidence High willingness to learn Communication skills Flexibility Assertiveness Negotiation skills
Structured Self-motivated Analytical Organized Solution-oriented Resilient Team-oriented
Education
At least Bachelor Master Diploma or Similar e.g. Professional training for PTA (f/m/x) and Several years of work experience
Chemistry, Physics & Biology
English Fluent Advantageous: German Good

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