A Position as a Validation & Calibration Specialist is required by a leading, privately owned Pharmaceutical Contract Research Organization. We offer extensive training, a long-term stable job opportunity, a competitive salary based on your capability, full benefits, education support where appropriate and an opportunity for you to expand your range of skills and knowledge by being involved in a wide variety of activities, from calibration and troubleshooting to writing SOPs and training other staff. This is an ideal position for an individual who currently possesses the skills listed below, but would like to expand his/her range of job responsibilities in order to improve his/her professional expertise. You will be reporting directly to the Director of Compliance & IT.
- Execute/conduct the calibration and preventive maintenance and the installation qualifications/operation qualification/performance qualification (IQ/OQ/PQ) program.
- Draft/revise and/or provide technical assistance with regards to standard operating procedures for all departments.
- Review/audit validation documentation for GxP compliance, current regulatory compliance, validation and quality expectations.
Education / Skills / Expertise Requirements:
- University degree in chemistry, biochemistry, or related scientific field from an accredited post-secondary institution
- Preferably 3 or more years experience working with various makes and models of analytical equipment, software and processes, such as HPLC, GC, CHEMSTATION, OPENLAB, ion chromatography, fluorescence detectors, differential refractometer detectors, dissolution autosamplers and stability chambers. EXPERIENCE WORKING WITH HPLC IS A MUST.
- Sound analytical and/or technical knowledge
- Proven computer skills, knowledge and basic experience conducting calibration, preventive maintenance and IQ/OQ/PQ on analytical equipment
- Solid understanding of regulations, such as 21CFR Part 11, Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP)
- Proficiency in Word and Excel
- Exhibit good communication, organization, people management skills and resourcefulness
- Extended health care
- Dental care
- Life insurance
- Company pension
- Disability insurance
- Vision care
Job Types: Full-time, Permanent
- Validation & Calibration : 3 years (Required)