Quality Control Technician - Multinational Pharmaceutical Client / Netherlands

We are recruiting QC Technicians (contract roles) on behalf of a Multinational Pharmaceutical Client located in the Netherlands.

Objective

Support the value stream organizational structure, take care of all non-routine Quality Control activities for example:

• Laboratory Quality Control Product Specialist (Knowledge of specific product characteristics)
• Lead of phase II OOS- en complex investigations
• Stability trending,
• Lab Outsourcing,
• Quality Analyst Job Training
• Equipment care (maintenance/validation/calibration)
• SME during Regulatory and client inspections
• Quality Control testing
• Back-up for testing and evaluation of quality of Raw materials, API, Packaging components (primary and printed) Drug Product throughout manufacturing process and during shelf life of the drug product (Stability testing)

Responsibilities

• Accountable for day to day testing activities in according with cGMP guidelines, Global Standard and local GMP as well as EHS SOP's.
• Accountable for day to day testing activities in according with Site manufacturing planning and agreed lead times.

Qualifications:

University level (Pharmacy / Analytical Chemistry) or

HBO+

Specific Training (internal and / or external and experience)

• Experience with pharmaceutical processes, chemical analysis techniques, and cGXP
• Experience on instrument like HPLC, GC, KF.
• Familiar with process automation.
• Familiar with Lean Lab concept.
• Experience & exposure to work in regulatory environment as well as Regulatory Audit like EU cGMP inspection, US-FDA, ANVISA
• Good Knowledge of English (verbal and in writing)

Knowledge / Technical Competencies:

Technical Competencies

• Should have a good knowledge of HPLC and other instruments operation.
• Should have sound knowledge of all analytical equipment and techniques
• Capable to handle all modern sophisticated instruments used in analysis of drugs, well versed with analytical methods and procedures.

Regulatory authority inspections

• Ability to collaborate with internal team to manage a successful inspection and provide timely and thorough responses to the regulatory authority
• Ability to draft response to inspection observations
• Ability to share information with internal colleagues regarding status of inspection and responses

Knowledge of cGXPs

• Ability to apply in daily activities a strong working knowledge of cGXPs/ regulatory guidance's to ensure full compliance
• Ability to ensure that all laboratory standard operating procedures are accurate, current with regulatory guidance and aligned with cGXPs

Knowledge of relevant regulatory guidance's

• Appropriate ICH Guidelines
• Regulatory Agency/Industry guidance's and Pharmacopeia Guidance's and Requirements including local regulatory requirements

Ability to understand and execute against the Department Quality Management System

• Understands the meaning and impact of Lab quality metrics and agility in appropriate and timely course correction and resolution
• Prioritizes OOS Investigations and CAPAs based on impact to business and completes them thoroughly, on-time and in sustainable fashion
• Completes Stability Testing and OOS investigations on time

Ability to promote continuous process improvement/ efficiency

• Ability to proactively analyze and assess laboratories processes and make proposal for improvements resulting in compliant, effective and efficient operations for quality and the site.
• Understands the meaning of OpEx (such as workplace organization, 5S, root cause analysis, continuous improvement, standardization, poke yoke).