Senior Scientific Associate Metrology and Calibration (897260-MGP)

Location
Canton of Basel-Stadt (CH)
Salary
negotiable
Posted
19 Feb 2021
Closes
26 Feb 2021
Discipline
Quality, GLP, GMP, R & D , Laboratory
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Providing Flexible Resourcing Solutions

Founded in 1997 and headquartered in Basel, Switzerland, CTC is a specialist life-sciences recruitment organisation. We place specialist talent into contract and permanent positions in the pharmaceutical, biotech, medical devices and CRO industries.

An in-depth experience in life-sciences recruitment combined with an established and extensive local network means that CTC offers clients and candidates the “Gold standard” in recruitment services. With an expertise honed over many years at the cutting-edge of the life-sciences industry, we help companies find people and we help people find companies.

 

Senior Scientific Associate Metrology and Calibration (897260-MGP)

 

 

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a Senior Scientific Associate Metrology and Calibration for a permanent position based in the Basel area.

Main Responsibilities:

  • Responsible for metrological activities for Analytical Development and Quality Control Laboratories;
  • Supporting the development and evaluation of GMP analytical systems in ADQC labs, including: verifying that systems are working properly, organizes repair if needed prior to releasing to analyst, reviewing calibration certificates and investigating if failures occur;
  • Contacting and negotiating with vendors and contractors for the repair, calibration, preventive maintenance and qualification of analytical instruments;
  • Investigation and evaluation of the instruments if there is failure during analysis or testing;
  • Working with QA and the labs to develop corrective action and preventive action;
  • Being involved in qualification and validation activities, including generating user requirements and generating, reviews, and executes the IQ/OQ/PQ (installation, Operational and Performance Qualification) protocol for the new and existing instruments, writing the summary report and explains in writing with QA if there is any deviation;
  • Supporting procurement of instruments by evaluating compliance to regulations;
  • Coordinating Maintainance, repairs, calibrations, and qualifications from simple to moderate analytical instrumentations in both QC and A&D laboratories to ensure that all analytical instruments are in good working condition in compliance with cGMP;
  • Minimizing instrument downtime, reduces cost and maximizes availability by ensuring that instruments are repaired on time and calibrated / qualified in a timely manner to increase lab efficiency and productivity;
  • Generating respective documentation for new instrument purchases;
  • Generating Change Controls through Veeva system and the IT Change Management System to support instrument installs and relocations;
  • Reviewing qualification/validation protocols and ensures complete adherence to protocols during executions. Work with QA to obtain pre-approval of protocol and approval of reports;
  • Working closely with IT to implement new software technology and support upgrades for existing software;
  • Works closely with Engineering to coordinate site prep for new instrument installs or relo’s;
  • Maintaining SOP calibration, qualification and related records. Monitors industry sector trends to maintain compliance with FDA, USP and other industry recognized agencies;
  • Writing/revising SOPs and qualification protocols of new and existing instruments to mantain compliance;
  • Writing internal calibration procedures;
  • Establishing instrument ranges and tolerances;
  • Supporting QA and FDA walk-through Audit and provides responses to QA and FDA observations.

 

 

Qualifications and Experience:

  •   Bachelor’s degree or Master’s degree in chemistry, Biochemistry other relevant science discipline required with at least 4 years of experience working in a biotechnology or pharmaceutical company in a technical role;
  • Must have hands-on maintenance and calibration related experience for equipment used in QC and R&D Laboratories including but not limited to: HPLC,UPLC, GC, UV/Vis, FTIR, Particle Size Analyzers, and Dissolution systems. Working knowledge of Waters Empower Chromatography Data Acquisition Systems;
  • Knowledge in Analytical Equipment Qualification that includes IQ/OQ/PQ and qualification lifecycle;
  • Familiar with chromatographic data systems/databases, such as Waters Empower application software;
  • Good understanding of cGMP and FDA requirements (21 CFR Part 11 and part 211);
  • Able to troubleshoot and maintain simple to moderate analytical laboratory instruments such as HPLC, UV/Vis, GC, Dissolution Testers, and FTIR;
  • Working knowledge of Empower, Chromeleon, Veeva software;
  • Experience working with multidisciplinary teams in a matrix environment;
  • Broad understanding of biopharmaceutical analytical activities;
  • Experience with evaluating and implementing new and novel technologies;
  • A good understanding of cGMP, CSV and data integrity principles;
  • Good organization/time mgt skills; manage time effectively to complete assignments in expected time frame;
  • Relevant working/residency permit or Swiss/EU-Citizenship required.