QC Technician

Location: Netherlands

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Noord-Holland Netherlands.

Role Description

Support the value stream organizational structure, take care of all non-routine Quality Control activities for example:
o Laboratory Quality Control Product Specialist (Knowledge of specific product characteristics)
o Lead of phase II OOS- en complex investigations
o Stability trending,
o Lab Outsourcing,
o Quality Analyst Job Training
o Equipment care (maintenance/validation/calibration)
o SME during Regulatory and client inspections (Quality Control testing)
o 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)
o Back-up for testing, approve or reject of the raw materials, packaging materials & finished products, stability samples as per the committed time lines.

Responsibilities

Responsibilities
• Accountable for day to day testing activities in according with cGMP guidelines, Teva 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.

Handling failure investigations.
o Timely management of (OOS) investigations, CAPAs, Regulatory commitment, GRAs, Audits, Teva Global Standard implementation to ensure sustainable compliance.
o Write study protocol and report as part of failure investigations.
o Actively participate in advanced problem solving, root cause analysis, troubleshooting, interpretation/consultation, verification of quality and test results discussions.
o Effectuate agreed arrangements on deviations and reporting on progress.
o Support Complaints investigation by developing test methods and performing the test accordingly.

Documentation
o Assistance in the establishment of standards, specifications, sampling plans, test procedures, or any other laboratory control mechanism.
o Assistance in the development and implementation of the quality control programs to ensure reliability of testing procedures, proper function of laboratory equipment and compliance with regulations; prepare and maintain applicable records.
o Handling in the preparation, review and finalization of specifications, standard test procedures and standard operating procedures.
o Participate in the development of new laboratory procedures and techniques; plan, develop and present workshops.

Stability:
o Handling stability studies as per the regulatory requirement.
o Timely preparation, review and approval of stability trend & evaluation reports.
o Participate in site stability meetings

Outsourcing
o Assistance in selection, audit & approval of contract laboratories.
o Managing outsourced QC laboratory activities (review, shipment, planning, progress, timely delivery).

Qualification
o Maintain own technical expertise, personal skills and interpersonal skills needed to perform their duties in line with Teva and Site expectations.
o Demonstrate decision-making abilities in all aspects of performance.
o Trains and/or supervises training of other lab staff.
o Coordinate employees rotations to include instruction in laboratory methods and procedures.

cGXP
o Implement department policies and objectives in line with Teva and Site Policies.
o Execute the implementation of and compliance with national and international quality standards (cGXP) as well as Teva Global standards
- Timely implementation of validated Analytical methods
- Execute the review and implementation of Teva standards and procedures at the department.
- Maintain adherence to corporate policies and appropriate regulations through actions and decisions.
- Initiates corrective action as soon as deficiency is identified; completes checklist and other information sheets required and coordinates on-site inspection of sections for which responsible.

Face of the Site
• Regulatory authority inspections:
o Develop as Subject Matter Expert (SME) of the laboratory and develop a productive and proactive attitude during self-inspection, global audits and regulatory inspections.
• Represent the department from a quality perspective to customers and professional.

Requirements

• MSc. in Pharmacy or Analytical Chemistry
• 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)

Other information

Note! This position is in shifts.

The times are:
07.00 - 15.30
15.00 - 23.30
23.00 - 7.30

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rowin van der Zwaan.