Job Opportunities in Turkey
July 2, 2024
Sandoz
Gebze
OTHER
Qualification & Maintenance Specialist
· To ensure that GMP requirements defined by Sandoz Quality Manual are completely and effectively implemented.
· To abide to the c GMP & GLP rules.
· To research all information about instruments and software problems for laboratory equipments, to estimate these information, and to solve these problems.
· To follow the maintenance and calibration processes for laboratory instruments. Carrying out the calibration test or controlling the finished calibration.
· To assisting the technical service personnel from coming the vendor firm, to provide the required support for solving the problem.
· To prepare the requalification documents for the existing instruments in laboratory and to prepare or to ensure preparing the qualification documents for purchasing new instruments, to carry out the essential tests.
· To perform the laboratory equipment computer system validation.
· To perform the computerized systems equipment qualification / re-evaluation master plan.
· To perform the computerized systems periodically review.
· To perform the computerized systems activities according to international standards defined in c GMP regulations, 21 CFR Part 11 of FDA guidelines.
· To perform or to ensure to perform the works in laboratory in compliance with relative SOPs (Standard Operation Procedure) and make being appied new methods fully.
· To make the revision of the SOPs which are responsible from and to give the trainings of the revised SOPs.
· Minimum Requirements:
· University degree in Pharmacy, Chemical Engineering or Chemistry
· Minimum 5 years of Analytical Laboratory experience with equipments e.g. HPLC, GC,
· Preferably experience at a pharmaceutical company with FDA approved.
· Knowledge of c GMP& c GLP and basic SAP.
· Ability to work in a fast-paced changing environment
· Team working and customer-oriented mindset
· Good analytical thinking skills
· Strong interpersonal written and verbal communication skills
· Good knowledge of MS Office applications
· Good command of English is required
Work Experience:
· To abide to the c GMP & GLP rules.
· To research all information about instruments and software problems for laboratory equipments, to estimate these information, and to solve these problems.
· To follow the maintenance and calibration processes for laboratory instruments. Carrying out the calibration test or controlling the finished calibration.
· To assisting the technical service personnel from coming the vendor firm, to provide the required support for solving the problem.
· To prepare the requalification documents for the existing instruments in laboratory and to prepare or to ensure preparing the qualification documents for purchasing new instruments, to carry out the essential tests.
· To perform the laboratory equipment computer system validation.
· To perform the computerized systems equipment qualification / re-evaluation master plan.
· To perform the computerized systems periodically review.
· To perform the computerized systems activities according to international standards defined in c GMP regulations, 21 CFR Part 11 of FDA guidelines.
· To perform or to ensure to perform the works in laboratory in compliance with relative SOPs (Standard Operation Procedure) and make being appied new methods fully.
· To make the revision of the SOPs which are responsible from and to give the trainings of the revised SOPs.
· Minimum Requirements:
· University degree in Pharmacy, Chemical Engineering or Chemistry
· Minimum 5 years of Analytical Laboratory experience with equipments e.g. HPLC, GC,
· Preferably experience at a pharmaceutical company with FDA approved.
· Knowledge of c GMP& c GLP and basic SAP.
· Ability to work in a fast-paced changing environment
· Team working and customer-oriented mindset
· Good analytical thinking skills
· Strong interpersonal written and verbal communication skills
· Good knowledge of MS Office applications
· Good command of English is required
Work Experience:
· Sound technical & scientific knowledge of pharmaceutical/ chemical. analytics/QC/R&D/ equivalent.
Skills:
Skills:
- Communication Skills.
- Continuous Learning.
- Dealing With Ambiguity.
- Decision Making Skills.
- Gxp.
- Industry Standards.
- Laboratory Equipment.
- Laboratory Excellence.
- Self Awareness.
- Technological Expertise.
- Total Quality Management.
- English.(Advanced)
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