- Ensure that products manufactured meet approved company policies, processes and procedures
- Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities.
- Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g., QA Hold, QA tag out.
- Release incoming material, process, and product batches.
- Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product.
- Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies.
- Perform regular walk-through of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times.
- Participate and support new product introduction, operation excellence projects and other tasks as assigned by management
- Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Engineering, Pharmacy or other relevant courses
- Prior knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics
- Minimum of 2 years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment.
- Experience in SAP, Trackwise are preferred
- Ability to quickly know products and processes in order to assess quality issues
- Committed to quality and maintain a high standard of work at all times
- Demonstrates the highest levels of integrity and a strong work ethic
- Good knowledge of GxP requirements and regulations
- Good planning and scheduling skills
- Good communication and interpersonal skills both verbal and written
- Must be team player, meticulous, strong analytical and organizational skills
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Quality Operation Specialist - Singapur, Singapore - Amaris Consulting
Description
Job description
Amaris will be prioritizing applicants who are currently based in Singapore.
Responsibilities:
Qualifications
Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability or other characteristics.
