Job Post no longer active
Current vacancy of
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.
All Details on the Position
All Details on the Position:
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
10-15 direct colleagues
Diverse / From young to old
Nationwide
International
English
German
Flat hierarchies
Reporting to
> Team lead
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
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
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
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
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
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
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
Interested? We'll answer questions and put you in touch:
Send questions via email