Lab Head/Lab Coordinator (QA) /no-493

Status: 
closed
Location: 
Stein (CHF)
Start Date: 
2018-10-01
End Date: 
2018-12-31
Hours per day: 
8,00
Hours per week: 
40,00
Workload: 
100%
Total Hours: 
528
Assignment: 

Background

For our Swiss customer located in Basel we are currently looking for (m/f) an Lab Head/Lab Coordinator (QA)

  • Type of placement:  3 months, external contract with possible long term extension
  • Company:  major Pharma company in Basel area
  • Salary:  level 2, please ask us for the exact rate range 

IT: (monthly all in salary levels in CHF,  level1= 5-10k , level2=10-15k,  level3= >15k)

 

Job Purpose

The overall objective of the role consists of: 

  • 1. Deviation handling 
  • 2. Microbiological QA-Oversight including coaching activities and trouble-shooting in context with sterile drug products/ aseptic processing 
  • 3. Media fills 
  • 4. Trending of microbiological environmental monitoring 
  • 5. Technical release microbiology of sterile product and water 
  • 6. Support, preparation and participation of authority or customer inspections and registration 
  • 7. Additional tasks including the function as a contact to facilities outside NTO Aseptics Steriles 

 

Major accountabilities

 

  1. Deviation handling 

  •  Coordination of the handling and decision of “critical” and “non-critical” microbiological deviations including approval of the respective microbiological   risk assessment of batches involved. Based on this sterile drug product batches are released or rejected. 
  •  Definition and tracking of CAPAs for preventing recurrence of deviations 

 

  2. Microbiological QA-Oversight in context with aseptic processing 

  •  Support of production in the (re-)qualification of clean room personnel and operator trainings. 
  •  Supervision and periodic checks of the aseptic working technique during Media Fills or on surprise (VIMOS) 
  •  Assurance and optimization of microbiological routine environmental monitoring and monitoring on surprise (EMOS). 
  •  Microbiological trouble-shooting between PUs and SUs 
  •  Support of PUs regarding qualification/validation of clean rooms, equipment 

 

    3. Media Fills 

  •  Assurance and optimization of validation of aseptic processes by Media Fills in time. 
  •  Establishment of the annual Media Fill program 
  •  Approval of MBR (PMX and MES) 
  •  Review and release procedure for all Media Fills 

 

  4. Trending of microbiological environmental monitoring 

  •  Perform trend analyses/reports (incl. findings) of the environmental monitoring on a routine basis. 

 

   5. Microbiological release of sterile product and water 

  •  Evaluation of relevant product, process and facility related microbiological aspects (BET, sterility and BB tests) as well as the findings of environmental monitoring, water analyses and Media Fills. 
  •  Perform short term planning and tracking of due dates for sterile drug products in collaboration with PUs and SUs. 

 

    6. Support, preparation and participation of authority or customer inspections and registration as a biological/microbiological expert 

  •  Cooperation with registration department and authority reviewers in order to optimize the quality of the (re-)registration documents. 
  •  Dealing with authority questions related to the microbiology of sterile products in conformity with international/ local legislation and guidelines as well as with  QMs    and SOPs. 

 

     7. Additional tasks 

  •  Creation, update and approval of SOPs, statements and risk assessments 
  •  Contact to functions outside NTO Aseptics Steriles 
  •  Giving external presentations (e.g. international congresses). 
  •  Adherence to the safety and ecology guidelines. 
  •  Archiving documents of the team, according to the requirements of the relevant SOP.
Requirements: 

Relevant Experiences: 

  • Biological/microbiological analytics or diagnostics including aseptic working techniques;
  • quality control/ assurance in pharmaceutical industry or biotechnology, especially with regard to sterile products;
  • manufacturing of sterile drug products and aseptic filling. 

 

Education (minimum/desirable)

  • (Technical) University/academy degree in general or medical microbiology, biochemistry, pharmacy or equivalent. 

Languages

  • German: fluently spoken/written 
  • English: fluently spoken/written