Quality Operations Specialists must assist site management to oversee the quality system execution on the manufacturing and production areas at all times.
The personnel are required to observe, document, discuss, and report quality adverse events related to the manufacturing of the product and are responsible to ensure highest quality and compliance of released batches.
Responsibilities:
- 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
About You:
- 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 the implementation /execution/review of electronic batch records
- Experience in the management/review of NCRs and Change Controls
- 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
Contract Role.
