QC Technician
SIRE Life Sciences
Unknown, nl
9 dagen geleden
source : Jobbird

SIRE Life Sciences® 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 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 :

oLaboratory Quality Control Product Specialist (Knowledge of specific product characteristics)

oLead of phase II OOS- en complex investigations

oLab Outsourcing,

oQuality Analyst Job Training

oEquipment care (maintenance / validation / calibration)

oSME during Regulatory and client inspections (Quality Control testing)

oBack-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)

oBack-up for testing, approve or reject of the raw materials, packaging materials & finished products, stability samples as per the committed time lines.

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.

    oTimely management of (OOS) investigations, CAPAs, Regulatory commitment, GRAs, Audits, Teva Global Standard implementation to ensure sustainable compliance.

    oWrite study protocol and report as part of failure investigations.

    oActively participate in advanced problem solving, root cause analysis, troubleshooting, interpretation / consultation, verification of quality and test results discussions.

    oEffectuate agreed arrangements on deviations and reporting on progress.

    oSupport Complaints investigation by developing test methods and performing the test accordingly.

    Documentation

    oAssistance in the establishment of standards, specifications, sampling plans, test procedures, or any other laboratory control mechanism.

  • oAssistance 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.

    oHandling in the preparation, review and finalization of specifications, standard test procedures and standard operating procedures.

    oParticipate in the development of new laboratory procedures and techniques; plan, develop and present workshops.

    Stability :

    oHandling stability studies as per the regulatory requirement.

    oTimely preparation, review and approval of stability trend & evaluation reports.

    oParticipate in site stability meetings

    Outsourcing

    oAssistance in selection, audit & approval of contract laboratories.

    oManaging outsourced QC laboratory activities (review, shipment, planning, progress, timely delivery).

    Qualification

    oMaintain own technical expertise, personal skills and interpersonal skills needed to perform their duties in line with Teva and Site expectations.

    oDemonstrate decision-making abilities in all aspects of performance.

    oTrains and / or supervises training of other lab staff.

    oCoordinate employees rotations to include instruction in laboratory methods and procedures.

    cGXP

    oImplement department policies and objectives in line with Teva and Site Policies.

    oExecute 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 :
  • oDevelop 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

    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.

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