QUALIFICATIONS AND JOB DESCRIPTION
- 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
- 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.