Responsible for QA On the Floor support to the Packaging Operation. Partners up with production to ensure that processes are carried out in compliance with approved standards. Primary responsibilities include AQL Sampling and inspection, line monitoring and Line Clearance inspections.
Responsibilities:
Qualifications:
Responsibilities:
- AQL Sampling and inspection of final product containers and packaging.
- Oversight of Packaging Operations through line monitoring.
- Line clearance inspections during the changeover process.
- Maintains a high level of understanding of relevant production processes and quality systems.
- Collaborates with Packaging personnel and other Quality professionals to ensure consistent application and execution of key quality systems.
- Executes QA processes to maintain the flow of products and documents to meet site objectives.
- Ensures that training is up to date and all tasks are completed per SOP or other defined standard.
- Uses lean principles to make suggestions on opportunities to reduce waste and improve processes in Quality Operations.
- Reports potential issues of non-compliance.
Qualifications:
- Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering preferred
- 2 years experience in pharmaceutical industry in roles covered by GMP oversight
- Excellent interpersonal and communication skills
- Ability to perform mathematical calculations to determine sample size and acceptance criteria.
- Desirable Skills: Knowledge of Data Integrity, Lean Manufacturing and/or previous QA experience