Quality Manager a.i. - Michael Page International Netherlands SA
Amsterdam, NH 1066TK
Over de vacature
Monitors Supply Chain Quality and is responsible for overseeing the compliance of operations with relevant legal and regulatory compliance standards. May act as a licensed Responsible Person.
Client Details
My client is a global leader within healthcare, producing and selling drugs, vaccines around the globe with 100 000+ employees.
Description
- Implements and maintains the Quality Systems for Supply Chain and GxP related activities
- Coordinates and supports GxP Quality Systems related to the distribution activities (documentation systems, complaints and product event handling, recalls, internal and external audits), including trending and continuous improvement initiatives
- Defines, interprets and recommends modifications to Global and Regional quality policies and guidelines in a constructive and pro-active manner
- Works on complex matters related to GxP compliance processes (analyse and determine requirements in case of complex change requests, perform organizational diagnosis and gap analysis at all levels of EMEA organization)
- Interprets law, regulations and policies for their relevance for future process improvements and performs a gap analysis against these regulations for existing processes
- Implements and maintains quality standards procedures
- Interprets audit and inspections trends and prepares (and when necessary, supports the implementation of) action plans based on these findings
- Executes and reports risk assessments, and implements risk mitigation projects, policies and systems
- Integrates current legal and regulatory standards and competent authority expectations, as well as Global e-compliance standards and strategies.
- To ensure that the provisions of the licenses are observed
- Advises on GDP standards (Ref 1) and is accountable for the implementation of relevant changes and improvements
- Responsible for the implementation of GDP best practices and alignment with relevant counterpart
- Plays a leading role in product release activities
- To take part in all batch recalls and advise on any GDP issues that may arise Reports deviations from GDP to competent health authorities (IGZ)
- Coordinates, prepares and executes controls, inspections, audits with clients and suppliers
- Is responsible for the delivery of GDP training to personnel
- Serves as (one of the) company representative(s) during competent authority inspections
- Responsible for the process of risk assessment, mitigation and escalation, including trending
- Participates in deviation, customer complaint investigations and review of change controls
- Regulatory compliance checks and license maintenance
- Mentoring and support for trainee RPs
- Maintains (and/or supports the maintenance) of quality systems according to stringent regulations
Responsible for the delivery of complex cross functional / regional projects, from setup through execution and reporting to closure
Uses best practices and knowledge of internal or external business issues to develop and implement improvements
Actively participates in and contributes to global business process improvement activities, representing the regional business view
Discusses with an provides information to:
Leads multifunctional teams and/or projects
Profile
- Masters degree, preferable in biosciences (pharmacy, biotechnology)
- Additional qualification as an industrial pharmacist or GDP Responsible Person is preferred
- At least 4-7 years of experience in the pharmaceutical industry in a similar position
- Proven experience in having led processes improvement, compliance and auditing activities is required
- Experience with and knowledge of Quality Systems (GMP, GDP) is a must
- Has an analytical and pragmatic, problem solving approach
- Strong planning, project, process, time, budget and people management abilities
- Excellent judgement with an eye for detail
- Strong communication, negotiation and networking capabilities
- Team player and to be able to work with several disciplines in a multicultural setting
- Is able to lead and organize others without having direct authority
- Is able to multi-task, prioritise and performs well under pressure
- Result driven
- Leads projects and may lead functional (project) teams
- Leads the delivery of assignments and organizational goals
Job Offer
4 months assignment with possible extension. Starting date ASAP
If you are passionate about quality and wants to share and improve the system this mission is for you.
Salaris
3,500 - 5,000 /maand
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