Davipharm

Job description:

• Prepare all activities according to the EU GxP general rules and company SOPs
• Prepare sample, analyze sample, calculate the results and prepare report, COA for physicochemical test
• Develop and update SOP.
• Prepare the protocol, report, perform validation analytical method, cleaning validation, transfer of analytical method, dissolution profile, remediation.
• Prepare the URS and risk assessment.
• Checking and reviewing analytical reports
• Participating in investigation of OOX, deviations, implementing CAPA and change control.
• Ensuring the data integrity during working
• Be auditor or lead auditor of the internal audit and audit the suppliers
• Take part in the internal audit and audit by the third part, GMP WHO, EU).
• Training employees the related procedure, contents upon request.
• Perform according to the assigned tasks from team leader.
• Preparation of general-purpose reagents, performing standard solutions, indicators, buffers, etc.
• Checking room and equipment temperature, humidity in physicochemical Laboratory and record results.
• Supervising the assigned control and measurement equipment
• Conducting and documenting testing in the scope of physicochemical analysis with all methods used in the laboratory.
• Report to the person responsible about of the status quantity, expiry, quality of chemical/standards.
• Participation in OOX investigation, deviation.
• Developing and giving opinions on the implementation of the quality system in the Quality Control Laboratory (instructions for equipment).
• Training new laboratory staff.
• Training employees the related procedure, contents upon request.
• Preparing, checking analytical reports and Certificates of Analysis.
• Performing the transfer of analytical methods transferred from another laboratory. Participation in the implementation of new products in analytical subjects.
• Solving everyday problems related to testing of raw material, finished product, stability studies and in-process control.
• Creating reports, summaries, summaries of the resulting investigations along with the interpretation of the results and recommendations received.
• Issue of CAPA cards and CHC applications and their coordination within the defined scope. Participating in CHC requests from other departments
• Prepare the protocol, report, perform validation analytical method, cleaning validation, dissolution profile.
• Participation in investigation of deviation, Preparation the CAPA, change control
• Participate in the risk assessment process
• Participate in URS drafting and validation of simple spreadsheet
• Guaranteed implementation the data integrity in QC department
• Opex management and budget controlling
• Report the Kaizen ideas to leader/ manager and take part in to prepare those potential ideas
• Receiving samples – Registering samples – Distributing samples – Archiving samples according to the approved procedure
• Performing the work of authorization of documents base on authorization from QC leader when absent
• Be auditor or lead auditor of the internal audit and audit the suppliers.
• Take part in the internal audit and audit by the third part, GMP WHO, EU).

Job requirement:

• College in pharmaceutical/ chemical/ biological field, at least.
• At least 3 years working in laboratory as a physicochemical analyst.
• Have knowledge of physicochemical analysis techniques.
• Good skill in operation of analytical equipment ((HPLC, UV-Vis, IR, Dissolution,…)
• Have knowledge of Good Laboratory practice (GLP) and Good manufacturing practice (GMP) rules.
• Ability to work under pressure high and intensive deadlines
• Ability to read and understand specialized English documents.
• Have ability to prepare bilingual documentation according to the internal procedures
• Ability to analyze problems and process on complex equipment and tests
• Good command of English is an advantage.

Please contact our Recruiter or apply via email recruitment@davipharm.info