Специалист по контролю качества

Key Responsibilities:

-To carry out raw material, product, and stability analyses received in the laboratory, as well as all related activities within the scope of analytical method transfer/validation/verification, process validation, and cleaning validation, in compliance with procedures and GMP, within the planned timelines; to ensure reporting and archiving of these activities,

-To monitor and/or perform identification, qualification, maintenance, consumables tracking, conformity checks, fault/error detection and reporting, review, cleaning, and verification of laboratory equipment; to prepare the necessary documentation and ensure its control,

-To investigate and ensure follow-up of any out-of-specification (OOS) results and deviations encountered,

-To prepare required SOPs related to laboratory equipment and laboratory operations, follow current procedures, ensure documents remain up to date, and revise them when necessary,

-To prepare, monitor, analyze, report, and control working standards and solutions used within the department.

Qualification & Requirement:

-Bachelor degree in Chemistry or Chemical Engineering.

-Minimum 2 years of experience in Quality Control processes within the pharmaceutical industry.

-Knowledgeable in the use and technical characteristics of HPLC, GC, and basic laboratory equipment.

-Experienced in method transfer, method validation, process validation, and cleaning validation studies.

-Capable of performing, monitoring, controlling, and documenting the required analytical studies of products.

-English proficiency

-Preferably experienced in using SAP, QMEX, and MS Office programs

-Analytical thinker with strong problem-solving skills; result-oriented, team-oriented, possessing strong communication skills, attentive, and principled.

-Able to adapt to flexible working hours and, if necessary, shift-based work.

-For male candidates, military service must be completed.

Key Responsibilities:

-To carry out raw material, product, and stability analyses received in the laboratory, as well as all related activities within the scope of analytical method transfer/validation/verification, process validation, and cleaning validation, in compliance with procedures and GMP, within the planned timelines; to ensure reporting and archiving of these activities,

-To monitor and/or perform identification, qualification, maintenance, consumables tracking, conformity checks, fault/error detection and reporting, review, cleaning, and verification of laboratory equipment; to prepare the necessary documentation and ensure its control,

-To investigate and ensure follow-up of any out-of-specification (OOS) results and deviations encountered,

-To prepare required SOPs related to laboratory equipment and laboratory operations, follow current procedures, ensure documents remain up to date, and revise them when necessary,

-To prepare, monitor, analyze, report, and control working standards and solutions used within the department.

Qualification & Requirement:

-Bachelor degree in Chemistry or Chemical Engineering.

-Minimum 2 years of experience in Quality Control processes within the pharmaceutical industry.

-Knowledgeable in the use and technical characteristics of HPLC, GC, and basic laboratory equipment.

-Experienced in method transfer, method validation, process validation, and cleaning validation studies.

-Capable of performing, monitoring, controlling, and documenting the required analytical studies of products.

-English proficiency

-Preferably experienced in using SAP, QMEX, and MS Office programs

-Analytical thinker with strong problem-solving skills; result-oriented, team-oriented, possessing strong communication skills, attentive, and principled.

-Able to adapt to flexible working hours and, if necessary, shift-based work.

-For male candidates, military service must be completed.