Global Supply Chain Transformation Project Manager

Amersfoort
5000.00 - 7000.00
40 uren
Bachelor degree

Opdrachtgever

Our client is a leading consulting and engineering firm in pharma, food and chemistry.

functie Vereisten

Education: University/Bachelor’s Degree or Equivalent Work Experience: 4-6 years of relevant work experience, preferably in the pharmaceutical or medical-device industry

Specific knowledge - Knowledge of GMP, MDD/MDR, QSR CFR 820, ISO 13485, ISO 14971 - Knowledge of quality assurance systems (QMS) - Knowledge of relevant work rules and procedures - Knowledge of MS Office - Knowledge of validation of technical systems and processes - Knowledge of statistics and quality improvement techniques Attitude/ Skills - Communicative - Flexible and accurate - Able to function both independently and in a team - Excellent command of Dutch and English language.

Important: medtech/pharma experience, validation experience, on-site minimum 4 days, senior QA engineer.

Wat krijg je?

Pension entitlement as from day one
Collective WGA / WIA insurance
NBBU / ABU collective labor agreement
25 holidays days
8,33% holiday allowance
100% payment in case of illness after one waiting day
Travel allowance

Werkzaamheden

· Administers the change control program and manages local procedures and specifications in the document control system.
· Leads efforts to comply with company policies, procedures, and quality standards; as well as safety and environmental regulations.
· Develops solutions to database problems of advanced scope and complexity.
· Writes and assists others in writing new or updated operating procedures.
· Generates, identifies, and suggests improvements in significant performance trends. Reports them to management and appropriate cross functional teams.
· Releases batches once it has been determined that all compliance and procedural requirements have been met.
· Investigates, tracks and trends customer complaints and provides complaint data for quality reports including annual drug product reviews, and monthly and quarterly complaint reports.
· Supervises external (including DEKRA/FDA) and internal audits (CQA). Addresses audit observations.
· Manages non-conformity.
· Advises, reviews, and approves changes in products/processes or systems, in line with the applicable procedures. Approves all QMS related procedures and work instructions.
· Assesses and determines specifications for raw and auxiliary materials, processes, semi-finished products and end products in relation to internal and external quality standards.
· Ensures continuous improvement of the focus area in response to regulatory developments, trends, deviations or other data-driven inputs.
· Investigates and resolves Corrective and Preventive actions (CAPAs).
· Analyzes and monitors trends in complaints, with which a possible structural deviation can be identified and corrected. Reports trends to stakeholders.
· Reviews and approves prepared complaint reports.
· Ensures the preparation and implementation of the complaint handling process within AMO Groningen in accordance with JJSV procedures.
· Rolls out Franchise procedures and regulatory standards.
· Manages the quality system.
· Support R&D function to ensure quality assurance within product and process development projects by:

Performing risk analyses
Drawing up the risk management plan and report
Drawing up validation plans and reports
Auditing the Design History File
Participate during Design Reviews

· Support Quality System:

Maintain the quality system
Franchise procedures and regulatory standards roll-out,
Compile and report metrics
Provide input to the Site Management Review
(Co-)supervising external (including DEKRA/FDA) and internal audits (CQA)

· Support Quality Operations by:

Addressing non-conformities within production and taking care of internal escalations
Guiding planned deviations from the production process
Advising, reviewing and (approving) changes in production processes, in line with the applicable procedures
Analyzing data on rejects within the production process for continuous improvement and reducing or eliminating sources of variation within the production process