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Quality specialist

Տոնուս-Լես

Երևան
6 հուլիսի
721

Main Duties:

·         Collaborate with Qualified person, Head of production and QM to ensure GMP compliance in a secondary packaging area of medicinal products.

·         Ensure new and existing personnel are adequately trained in the proper performance of their assigned tasks.

·         Develop validation protocols and reports.

·         Perform analysis of deviations.

·         Perform/participate in Quality System audits.

·         Manage CAPA, Deviation, OOS and Audit programs.

·         Participate in Quality management reviews.

·         Collaborate with QM to contribute to proper documentation system.

·         Participate in quality documents establishment, distribution and disposition control.

·         Perform compliance review on the following records: batch record, release data.

·         Perform suppliers’ assessment.

·         Assist departments in investigation and management of nonconformity events.

·         Develop audit schedule and ensure internal and external audits are completed as required.

·         Assist in management of customer complaint process.

·         Prepare and evaluate trends in quality system to monitor effectiveness. Develop metrics to support quality goals and objectives.

 

Required qualifications:

·      Master’s degree in chemistry, biochemistry, pharmacy or other related field

·      At least 3 years of experience in a similar position in drug production

·      Strong knowledge of GMP regulations

·      Excellent knowledge of Armenian, Russian and English languages

·      Strong computer skills (MS Office)

·      Excellent communication and presentation skills

·      High sense of responsibility

·      Detail oriented

·      Ability to effectively work in a team

·      Ability to multitask.

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ԿԱՄ

apply217455@job.am

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