Semdor Pharma Group GmbH
1 hour ago
Head of Quality Assurance (m/f/d)
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Company information
- Company
- Semdor Pharma Group GmbH
- Location
- Köln Germany
- Posted
- 1 hour ago
Job description
Your Tasks
Your Profile
Why Us?
- Technical and disciplinary leadership of the QA team of approx. 6 employees
- Further development of the Quality Management System (QMS) with regard to regulatory compliance and efficiency
- Ensuring compliance with GMP/GDP and MedCanG requirements
- Management of the core processes of the QMS: Document, Deviation, CAPA, Risk and Change Control Management, Complaints, Recalls, and Self-Inspections
- Responsibility for the supplier and service provider qualification system as well as contract/quality agreement management
- Management of approval documents (AmRadV, CTD dossiers)
- Ensuring the validation of computerized systems
- Preparation, accompaniment, and follow-up of authority inspections and customer audits
- Coordination of report creation (Management Review, KPI Reports, PQRs, Stability Reports)
- Close collaboration with the Qualified Person (QP) and other departments, e.g., Supply Chain, Regulatory Affairs, as well as sister companies
- Reporting to management
Your Profile
- Completed degree in natural sciences or engineering (e.g., Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Process Engineering) or many years of professional experience in relevant fields
- Several years of professional experience in Quality Assurance in a regulated environment, preferably in the pharmaceutical or medical device industry
- At least three years of management experience
- In-depth knowledge of relevant regulations (e.g., AMG, AMWHV, GMP/GDP guidelines, as well as MedCanG and/or BtMG, AmRadV)
- Very good German language skills in speaking and writing, as well as fluent English skills
- Structured, responsible way of working with a solution-oriented approach to challenges
- Communicative personality with assertiveness and a confident demeanor
- Enthusiasm for a dynamic environment and continuous change
Why Us?
- Flex Office
Want to change your workplace now and then? With our "Flex Office" model, you can also work flexibly from our offices in Munich, Hamburg, Leipzig, or London – for more variety, new perspectives, and maximum flexibility in your daily work. - Mobile Working
Want to work from home occasionally? With us, mobile working is possible up to 1x per week – in coordination with your team and fitting your tasks. - Time for You
Look forward to 30 days of vacation per year with a 5-day, 40-hour week – the half-days on Christmas Eve and New Year's Eve are given to you as extra gifts. - Urban Sports Club
Stay active, when and how it suits you: With the Urban Sports Club ("Classic" tariff) – with only a small co-payment. - Effortless Lunch
Don't feel like cooking? With Mealmates, your subsidized lunch comes to you easily. - Support for Families
We subsidize childcare for non-school-aged children with up to €250 per month – so you can concentrate on your job and family with peace of mind. - Experiencing More Together
Besides work, fun shouldn't be neglected: Summer parties, Christmas parties, and regular team events are part of our culture. - Thinking About Future Provisions
We support you in thinking about tomorrow today – with our company pension plan. - Further Development
Your development is important to us: We support you with further training and individual development opportunities. - Modern Working
So that you can work effectively, we provide you with modern equipment such as a laptop and – depending on the role – an iPhone. - Team Culture
Look forward to a respectful working environment, flat hierarchies, and an open "DU" (informal "you") culture.
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Required skills
- english
- assertiveness
- german
- engineering
- validation
- pharmacy
- leadership
- supply chain
- communication skills
- team management
- quality assurance
- further training
- process engineering
- audits
- quality management system
- vacation
- chemistry
- gdp
- contract management
- risk management
- professional development
- document management
- regulatory compliance
- dynamic environment
- laptop
- gmp
- qa
- biology
- team events
- team culture
- regulatory affairs
- pharmaceutical industry
- solution-oriented
- qms
- management experience
- biotechnology
- change control
- kpi reports
- modern equipment
- capa
- iphone
- flat hierarchies
- amg
- deviation management
- biochemistry
- structured work
- natural sciences
- btmg
- amradv
- company pension plan
- mobile working
- pqrs
- medical device industry
- urban sports club
- qp
- responsible work
- gmp guidelines
- qualified person
- du culture
- flex office
- supplier qualification
- amwhv
- complaints management
- childcare subsidy
- self-inspections
- management review
- mealmates
- recall management
- medcang
- service provider qualification
- ctd dossiers
- authority inspections
- stability reports
- computerized system validation
- quality agreement management
- approval documents
- sister companies
- gdp guidelines
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