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Salary:
Payment is negotiable
Published:
19.04.2016
Employment type:
City:
Moscow
Required experience:
Описание:
In a large original pharmaceutical company has an opening for a Microbiologist/Chemist-analyst
Responsibilities:
- Performs environmental monitoring in classified areas shall identify microorganisms.
- performs sampling of drinking water and purified water, controls their quality.
- Performs analysis of quality indicators on the basis of the quality certificate of the manufacturer when carrying out input control , incoming inspection, sterile packaging components, auxiliary materials, culture media, reagents/chemicals and disinfectants.
- monitors quality of finished products, products in storage in the Museum for legal samples and control the stability of a drug for microbiological and chemical-physical indicators.
- participates in the implementation of sanitary and hygienic control of production in accordance with applicable regulations and internal procedures.
- oversees the maintenance of the set temperature the thermostats and refrigerators, daily registers these indicators in appropriate journals.
- Carries out control of raw materials and control of finished products and products in storage at the Museum of legal samples in the framework of the input and output quality control by physico-chemical parameters.
- Develops and updates the protocols for validation of microbiological equipments.
- Develops protocols for validation of control methods and analytical equipment.
- Develop the working documentation and the protocols of disinfectants and validation of clean rooms.
- to participate in the development of manufacturing documentation within its competence (SOP for description of processes of quality control Department - description of equipment operation and another, the control and/or analytical sheets, specifications for reagents, standards, materials, equipment and facilities of the laboratory SOPS for quality assurance).
- tests for validation of control methods and manufacturing processes in accordance with the developed validation protocols, zapolnyaet reports of the validation.
- to Carry out the decontamination of spent culture media, suspensions of microorganisms, nutrient media with expired shelf life, etc.
- in a Timely manner makes the necessary changes to standard operating procedures and protocols validation.
- participate in the transfer of analytical methods before starting serial production and quality control of new products.
- participates in the sourcing and evaluation, if necessary, takes part in supplier audit, zapolnyaet reporting forms related to the implementation or audit of the provider.
- participating in determining the necessity and appropriateness of the purchase of certain equipment, consumable and support materials, determine their technical and other characteristics, to carry out a comparative analysis of prices for goods and services on the market, to inform the user about the necessity of the purchase.
- provides Timely ordering of reagents and materials for routine control commercial series, and through the transfer of analytical methods and registration of new products, to place an order in the electronic database EPOS.
- Monitors the presence and movement of reagents and materials (arrival/expense).
- Correctly and accurately fills the journals and checklists in the prescribed form.
- Timely perform necessary actions when the output of the controllable parameters beyond specification, analyzes the reasons and takes part in the development of the plan of measures on their elimination.
- Follow the schedule of calibration and verification of equipment in a timely manner, notify the head of the OCC and/or head of service quality in the case of non-compliance and/or change the timing calibration and verification of equipment.
- Complies with safety rules at performance of works with microorganisms of III–IV groups of pathogenicity.
- Complies with sanitary and hygienic requirements when working in the laboratory. organizes and participates in conducting health treatments classified areas of the laboratory and routine cleaning of premises and equipment OCC.
- Comply with traffic rules and flows of materials in laboratory and production premises and rules for the use of technological clothing.
- Systematically increases and improves its knowledge of the specialty.
- Participates in training (including through self-study).
- Performs periodic analysis of the influence of the Pharmacopoeia changes in the routine activities of the company, to register analysis data and transmit them to the head of the JCC for the global assessment of effect.
- In the case of production necessity performs a one-time job of the head of OCC, head of quality and Deputy General Director.
