Biocon Sdn Bhd is looking for new potential candidates to fill in for Drug Product Filling - Associate position. If you currently looking for new job opportunities and qualified with the job desc, feel free to apply this job.
- To ensure that all production activities are carried out in compliance with the cGMP requirements by strictly adhering to the standard operating procedures and good documentation practices.
- Ensures all team members strictly comply with cGMP procedures and immediately calls attention and corrects any member deviating procedures.
- Adherence to safety, health, hygiene and environmental measures.
- Candidates having on hand experience in pharmaceutical sterile formulation Area.
- Candidates having an sound knowledge on PCS-7 Automation system.
- Candidates shall be able to perform following activities as per Standard Operating Procedures below and having a sound knowledge on cGMP.
a) Monitoring of cleaning activities with correct disinfectant and frequency.
b) Monitoring and recording area differential pressure, temperature and relative humidity
c) Performing CIP and SIP OF Mobile Vessel
d) Performing Automation Formulation System (PCS-7) of Formulation Vessel, Filtration Skids and Transfer Vessel
e) Ensure cleanliness and sterilization of Formulation Vessel and Transfer Vessel.
f) Preparation of solution according to the different batches and the production plan for vials / cartridges.
- Comply in any other general SOPs and EOPs that related to production activities in PDP.
- Responsible for documentation specifically on preparation, review and revision of BMR, SOP’s, EOP’s, ECC’s.
- Responsible to fill in the required data in batch record online with correct GDP.
- 9 Ensure completeness of batch record before submitted to QA.
- Directly involved and having a knowledge on qualification and validation of equipment and process.
- Identification and raising deviation, change control and compiling other related documents in coordination with QA.
- Closely coordinates with the different department QA, QC, Warehouse, Instrumentation and Automation, and Maintenance for achieving the day to day production targets.
- Candidates having a knowledge on SAP system.
- Candidate must possess at least a Bachelor's Degree, Post Graduate Diploma, Professional Degree, Biology, Chemistry, Science & Technology, BioTechnology, Engineering (Bioengineering/Biomedical) or equivalent.
- Required skill(s): Fill Finish, Aseptic Environment, Grade A cleanroom.
- 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 Senior Executives specializing in Engineering - Chemical or equivalent.
- Applicant must willing take on routine 3 shift with 2 off days per week.
The attached document speaks about the journey and the many challenges and milestones encountered along the way. It talks of the Human Capital strategy of the company and how the Malaysia story is embedded in the same.
There were several steps which led to the success and many of them were differentiated with innovative ideas and sharp business acumen.
How To Apply
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