Biocon Sdn Bhd is looking for new potential candidates to fill in for Drug Product Compliance Associate position. If you currently looking for new job opportunities and qualified with the job desc, feel free to apply this job.
- Preparation of QA Standard Operating Procedures and review of Production and cross functional departments SOP prior to approval.
- Review executed Batch Production records, Deviation & Charge controls (if any), Components sterilization details, Legibility, Material reconciliation and Analytical records prior to batch release by QA.
- Review of Annual Product Review and Trend analysis for each Drug Substance.
- Review of trend chart for Environmental Monitoring Program and water/clean steam system.
- Perform routine GMP walk through Drug Substance manufacturing facility.
- Review of in-process checks at various stages of Drug Substances manufacturing.
- Responsible for day to day operations of Quality Assurance department which include complying of Standard Operating procedures/ Protocols and cGMP. Final lot / batch release procedures.
- Performing Quality Risk Assessments as per ICH Q9 and inculcate the culture of risk assessments.
- Identifying and leveraging opportunities to improve the quality systems and standards.
- Prior experience in handling the In-process /QMS Quality Assurance activities.
- Must have worked with pharmaceutical and / or Biopharmaceutical products.
- Should have hands on experience in handling of In-process Quality Assurance activities.
- Should have hands on experience in data analysis and all other critical Quality Management Systems.
- Experienced in handling regulatory audits such as EMEA/ USFDA audits.
- Experienced in ensuring that the facility is always under cGMP status hence assuring quality of the products manufactured.
- Experienced in handling validations related to operations.
- Must be team worker.
- Responsible and Reliable
- Confident with good communications skills.
- On hand experience in imparting training.
- Good time management skills.
- Good presentation skills.
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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