30 days old

Quality Control Technician

SAIC
Baldoyle, County Dublin
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Company Info

Teva is a global pharmaceutical leader and the worlds largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.  Our employees are at the core of our success, with colleagues in over 80 countries delivering the worlds largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and weve built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.  This is how we improve health and enable people to live better, healthier lives.  Join us on our journey of growth!

We would like to invite applications for the role of QC Technician at our site in Baldoyle, North Dublin.

The QC Technician is responsible for conducting raw material, in process, finished product, and where applicable stability testing according to relevant SOPs and in adherence to the site production schedule and for accurately completing all documentation that supports testing procedures. The QC Technician reviews all data and cGMP documentation generated by the Tosara Pharma QC Laboratory.The QC Technician identifies and troubleshoots issues related to laboratory testing and equipment that requires an in-depth knowledge of scientific methods and techniques. The position incumbent is expected to adhere to all cGMP compliance and regulatory mandates and quality requirements, and comply with all SOPs and internal Tosara policies and procedures in the performance of job duties. The QC Technician applies skills and knowledge to recognize and resolve issues that impact efficiency, throughput, quality, and/or the fulfilment of the assigned performance targets. The QC Technician is responsible for the safe, compliant, and efficient execution of job duties in a team environment. This position reports to the QC Manager.

This is a shift job and the succesful candidate will be on a 2 cycle shift, alternating weekly between:

Early shift   06:30 14:30 Monday Thursday, and 06:00 14:00 on Fridays.

Late Shift    14:30 23:00 Monday Thursday, and 14:00 20:00 on Fridays.

Responsibilities

  • Conduct chemical and physical laboratory tests and analyze raw materials, intermediates and final product to ensure compliance with standards. Complete all testing, including special project / protocol testing in a timely manner that supports established production targets and SLAs.
  • Maintain data integrity and ensure compliance with FDA, GLP, QSR and cGMP regulations, as well as with company SOPs and specifications.
  • Observe established escalation process for laboratory issues that impact established production-related Service Level Agreements (SLAs) and/or the fulfilment of production goals.
  • Participate in deviation investigations.
  • Author documents that ensure cGMP compliance, such as laboratory investigation, deviations, change controls, change notices, analytical test methods; analytical test method development reports; method validation protocols; method transfer protocols and reports; method verifications protocols and reports; and instrumentation qualification documentation (URS/IQ/OQ/PQ).
  • Carry out documentation review as per the agreed schedule.
  • Provide timely feedback to laboratory management on the quality and effectiveness of the laboratory documentation review process.
  • Perform routine review of documentation generated by the QC laboratory, such as auditing laboratory data and supporting documentation (instrumental printouts, COAs, chemist notebooks, cumulative stability tables, protocols, reports, laboratory investigations, analytical test methods etc.) generated to support commercial and development products for accuracy, completeness, and compliance to GMP requirements.
  • Monitor errors in laboratory documentation and work with laboratory supervisory personnel to correct documentation as needed.
  • Receive samples in the QC system.
  • Initiate investigations and write exception reports
  • Seek process innovation and continuous process improvement and perform quality improvement initiatives in the laboratory to meet site production goals.
  • Support and adhere to established processes and productivity targets.
  • Recognize and report to immediate supervisor any issues or deviations from accepted standards.
  • Provide status updates on own activities and productivity challenges according to defined procedures.
  • Complete and conform to all training requirements for job role, including company-required and job role-specific training. 
  • Carry out and assist in the on-going training of new and existing personnel, as appropriate.
  • Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses.

Qualifications

  • Minimum 2-3 years of relevant Quality Control experience or equivalent combination of education and experience
  • Experience in pharmaceutical manufacturing facility.
  • Demonstrate knowledge of cGMP requirements and practices including extensive knowledge of the USP and FDA Guidance Documents relating to the pharmaceutical Quality Control Laboratory.
  • Demonstrate competency in the operation, calibration and qualification of common analytical instrumentation e.g. HPLC, Dissolution, GC, FTIR, Electro Chemistry (DME), UV/Vis and other USP instrumental and Wet chemistry technologies used in pharmaceutical Quality Control Laboratory.
  • Demonstrate strong analytical laboratory skills and laboratory troubleshooting abilities.
  • Demonstrated success in making effective and persuasive presentations on complex topics to upper management.

 

Knowledge and Skills:

Computer literate; proficiency in using LIMS systems and Microsoft Office suite, and chromatographic software packages e.g. Empower

Function

Quality

Sub Function

Manufacturing Quality Control

Reports To

QC Manager

Tevas Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

Posted: 2018-12-20 Expires: 2019-01-20

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Quality Control Technician

SAIC
Baldoyle, County Dublin

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