Antalya
28 gün önce
yayınlandı
Job Type
Full-Time
Position Level
Specialist
Department
Quality
Quality
Application Count
120 application
Job Type
Full-Time
Position Level
Specialist
Application Count
120 application
Department
Quality
QUALIFICATIONS AND JOB DESCRIPTION
Qualifications:
- B.S,M.S,Ph.D degree in biology, biochemistry, microbiology, Biomedical or a related field
- Preferably A minimum of 3 years total work experience in healthcare/ biotech/ medical devices/ pharmaceutical industry
- Knowledge of tools/ methodologies such as investigation methods, process validation, statistical process control (SPC), protocol/ report preparation.
- Knowledge of ISO 13485, ISO 11135, ISO 11737-1, AAMI/ANSI ST72, ISO 14644,ISO 14698,ISO 11138, USP, EP and FDA requirements
- Good knowledge of MS Office applications is required and SAP is an asset
- Good command of English is compulsory, German knowledge would be an asset
- Exceptional analytical, problem solving & root-cause analysis skills
- Excellent communication skills, ability to work in a team environment and lead a project team
- Ability to lead or work with multi- departmental project teams and resolve quality related issues in a timely and effective manner
- Strong interpersonal skills and problem solving ability
- High level of attention to details, timeliness and accuracy
- Be self-motivated, self-starter, be able to meet deadlines, be a good team player
- No military obligation for male candidates
- Ability to work with external partners is required.
- Technical drawing interpretation
- Experience in microbiological testing like bioburden, bacterial endotoxin, particle testing,air samplingetc. İn pharmaceutical or medical device industries, sterilization process / validationand clenrrom validation/verificationexperience is an asset.
- Ability to interpret updates to applicable international standards related with sterilization/microbiology& chemicaland guidelines and implements these changes into the quality system
- Ability to solve process issues, perform root cause analyses, and implement process improvements
Job Description:
- Responsible for technical analytical test method development, validation, routine microbiological analytical test method validations, requalification activities related to medical devices and combination products.
- Responsible to review environmental monitoring data for cleanroom
- Responsible to review Cleanroom Validation/Qualification/Requalification Activities
- Support Sterilization Validation/Qualification/Requalification activities
- Support Laboratory Validation/Qualification/Requalification activities
- Applying Scientific/GMP theories, principles & techniques to solve problems.
- Contributes in trouble shooting/impact assessment for atypical conditions during routine testing/validations.
- Review product and process change control documentation and specifications
- Coordination of analytical test method validation/qualification and requalification activities with third part laboratories and Laboratory operation team
- Overview routine laboratory process
- Developing, validating and requalifying laboratory processes, test methods for new and existing medical devices and combination products.
- Supporting the creation of laboratory microbiological (BB-LAL-environmental) and chemical (EO/ECH) test methods and programs
- Responsible for providing scientific support and ensuring quality compliance in accordance with documented procedures for all aspects of functional responsibility
- Interprets updates to applicable international standards related with sterilization and guidelines and implements them into the quality system
- Reviewing and evaluating process issues, performing root cause analyses, and implementing process improvements.
- Record, analyze and interpret data
- Remain up to date with scientific and research developments
- Collaborating with team members and overseeing external partners (contact sterilizers, testing labs, etc) to achieve project objectives.
Preferred Candidate
More than 3 years of experience
Bachelor’s(Graduate)
Completed, Exempt
English(Reading : Good, Writing : Good, Speaking : Good)
Mikrobiyoloji Uzmanı pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.
Mikrobiyoloji Uzmanı Mikrobiyoloji Uzmanı Maaşları Mikrobiyoloji Uzmanı Nasıl Olunur? Mikrobiyoloji Uzmanı Nedir? Mikrobiyoloji Uzmanı İş İlanları
Medikal Ürünler
Şirketin Aydınlatma Metni
Detaylı Bilgiİlgini Çekebilecek İlanlar
Mikrobiyoloji Uzmanı pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.
Mikrobiyoloji Uzmanı Mikrobiyoloji Uzmanı Maaşları Mikrobiyoloji Uzmanı Nasıl Olunur? Mikrobiyoloji Uzmanı Nedir? Mikrobiyoloji Uzmanı İş İlanları