Monitoring and process control of specific operations.
Execute equipment qualification protocols and validation protocols.
Perform and document operations in accordance with cGMP.
Perform pH and conductivity measurements and filter integrity testing.
Assist with the planning of production schedules for unit operations.
Perform CIP, SIP of the Process Equipments in the assigned area of work.
Identification and raising deviations, change control and compiling with other GMP related documents in coordination with QA department.
Weighs and checks raw materials and maintains clean room environment to comply with regulatory requirements.
In-process product sampling, inspection and storage.
Maintenance of Production equipment in co-ordination with Maintenance Department.
To strictly adhere to the Standard operating procedures and Good documentation practices.
Reporting of non-conformity and implementation of corrective/ preventive actions in specific areas of operation.
Updating of BMR online, Log book/ Register, checklists. Record and maintain the daily reports.
Maintain 100% compliance with EH&S policies and procedures.
Preparation of Batch Manufacturing Records (Authorized person by Head of Department)
Preparation of SOP’s, ECC’s, EOP’s, Checklist and Log Sheets.
Co-ordination with shift in-charge and various other disciplines related to manufacturing, e.g.: QC/ QA, utilities and maintenance.
Ensuring compliance with cGMP policies and procedures.
Candidate must possess at least a Diploma, Advanced/Higher/Graduate Diploma, Bachelor's Degree, Post Graduate Diploma, Professional Degree, Master's Degree, in the Field of Biology/Biotechnology/Bioprocess Engineering.
At least 2 year(s) of working experience in the related field is required for this position.
Applicants must be willing to work in Nusajaya.
Preferably Associates specializing in Manufacturing/Production Operations or equivalent.
Full-Time position(s) available.
Knowledge of Purification, Chromatographic technics,downstream processing.
Knowledge of pharma or related industry is prefered.