Our client, an international pharmaceutical company (TOP-5 in Russia) is now looking for technologist.
Position Goal: Will be responsible for the initial Validation of company's assigned product (s). Owns the process knowledge of the product (s) assigned throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical parameters, ensuring process (es) are robust, in continued state of validation and continuously improving.
Key Job Responsibilities:
- support Validation Lead and Transfer Leads to assess need and plan validations/re-validations/verifications /Annula Monitoring Batches, consulting approving and reviewing the process validation master plan;
- approve both Validation Protocols and Report;
- participate and/or lead (case by case) the change controls to its products and related processes;
- ensure alignment of timelines for technical changes (e.g. DS), transfers or launch, major deviations;
- initiate and support investigations and improvement projects (quality, efficiency), based on the above data analysis, involving cross-functional teams;
- actively participate and represent product (s) in the relevant committee (e.g. Product Stewardship Committee), where the improvements on weak point products are planned, priorised and monitored;
- ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters.
Требования к квалификации:
- BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree;
- desirable MSc. or equivalent experience.
- minimum 1 year experience in process support, e.g. Process Expert role on the shopfloor of pharmaceutical manufacturing and/or QA/QC;
- proven process understanding (Pharma, GMP, Regulatory aspects);
- sound experience of data handling and applied statistics is a must.
Условия работы и компенсации:
- attractive salary and benefits
- health and life insurance
Контактное лицо: Самокиш Виолетта
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