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 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