jobid=A.0.0917
Product Complaint Inspection (PCI), Part time, Breda
Quality Assurance
Netherlands, Breda
Parttime
V-
Competitive
Introduction:
The company is one of the world’s leading biotechnology companies, dedicated to discovering, developing, manufacturing, and delivering innovative human therapeutics. Their mission is to serve patients, and they focus on areas of high unmet medical need, utilizing their expertise to strive for solutions that improve health outcomes and people’s lives. At their facility in Breda, they ensure that their medicines reliably reach the hands of patients around the world.
Objectives:
Perform complaint assessments in accordance with internal procedures, regulatory guidelines, and business performance objectives.
Own and/or act as QA contact for minor deviations.
Position Specific Tasks:
Initiate and own Minor deviations related to Product Complaint Inspection (PCI) Area activities.
Own training material related to PCI processes.
Own work instructions related to PCI processes.
Prepare metrics and own and maintain departmental performance boards.
Perform assessments in support of complaint investigations (e.g., Return sample inspection and Safety Features verification).
Partner with corporate product quality surveillance, assessors from other Company sites, and contracted partners to resolve product complaint investigations.
Prepare, review, and approve procedures or work instructions in compliance with corporate, site, and regulatory requirements.
Assist in local projects and improvement efforts as needed.
Provide training to local and global affiliate staff on performing investigations/assessments.
Participate in site regulatory inspections of complaint sample handling processes and in audits (internal and third party) as required.
Additionally, gain subject matter expertise in product complaint inspections and its related stakeholders.
Expectations/Scope/Complexity:
Knowledge:
Understanding and application of principles, concepts, theories, and standards in the technical/scientific field.
Specialized knowledge within own specialty area.
Deepens technical knowledge through exposure and continuous learning.
Knowledge of related regulatory/industry considerations, compliance issues, and/or scientific discovery.
Problem Solving:
Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope.
Ensures compliance within the regulatory environment.
Develops solutions to technical problems of moderate complexity.
Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues.
Interprets generally defined practices and methods.
Autonomy:
Works under general direction.
Work is guided by objectives of the department or assignment.
Refers to technical standards, principles, theories, and precedents as needed.
May set project timeframes and priorities based on project objectives and ongoing assignments.
Recognizes and escalates problems.
Contribution:
Contributes to work group/team by ensuring the quality of tasks/services provided by self.
Contributes to the completion of milestones associated with specific projects or activities within own department or workgroup.
Provides training/guidance to others and acts as a technical/scientific resource within work group/team.
Establishes working relationships with others outside the area of expertise.
Qualifications:
Master’s degree in Life Sciences or related field, or the equivalent combination of education and/or experience.
Typically, a half year of related experience.
Experience in Quality Assurance in the pharmaceutical industry.
Accurate mindset, flexible and proactive attitude.
Fluent in English.
What do we offer:
1 year contract for 24 hours
Salary between € and € based on fulltime and on skills and knowledge
30 holiday days
8.33% holiday allowance
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