R&D analyst
Росоман
Рок за пријавување:
- Синцеритас АД Скопје
- Адреса: Ул.Никола Кљусев бр.11, 1000 Скопје
R&D analyst
- Development of methods for physicochemical analysis applied to raw materials, trial / pilot batches, stability studies
- Perform analyses of raw materials, trial / pilot batches, stability studies
- Author of validation protocols of analytical methods
- Author of stability study protocols and reports
- Execution of validation of analytical methods
- Author of methods of analyses
- Transfer of analytical methods
- Ensure GMP compliant documentation in accordance to SINCERITAS standards
- Timely implementation, tracking, evaluation and release of validation protocols and reports changes, deviations, OOS results in the area of responsibility as well as definition of follow-up measures, work on projects in the field of laboratory analytical methods and represent the area of quality in cross-departmental projects (which affect the area of responsibility)
- Understand product specific control strategy and basis of specifications and critical quality attributes
- Leading laboratory investigations in support of production operations
- Demonstrate problem solving and investigative skills.
- Ability to make decisions based on knowledge, experience, standard processes, and requirements.
- Ability to work independently and accurately with minimal direction.
Qualifications
- Bachelor's degree in Pharmacy, Chemistry or related field.
- Advanced degree (master's, doctoral, specialist studies) is considered an advantage.
- Minimum 2 to 3 years in countertop analysis in a physical, chemical, pharmaceutical laboratory
- Experience to use instrumental analytical laboratory equipment: HPLC, GC, ICP, LCMSMS etc.
- Experience with computerized systems
- Reading and comprehension of pharmacopoeias, analytical methodologies of finished products and raw materials.
- Responsible for maintaining a safe work environment, working safely and accountable for supporting Health and Safety and Environmental corporate goals.
- Ability for independent and teamwork with scientific and technical staff.
- Excellent knowledge of work processes in the pharmaceutical laboratory for quality control, GMP, ISO.
- Self-motivated, detail-oriented, and willing to accept additional responsibilities.
- Good knowledge of written and spoken English.
Please send your CV using the Apply option.
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Административни професии изнесува 20.922 MKD.
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