Support day-to-day Quality activities in accordance with approved SOPs / Policies for a large scale, multi-product, GMP biotech contract manufacturing facility.
A good understanding of cGMPs and compliance in a GMP manufacturing setting performing both supervised and unsupervised tasks.
Receives minimal supervision and able to perform independently on routine assignments.
Can trouble-shoot. Able to weigh up all information and considerations in order to choose the optimum path to be taken.
Demonstrates ability to lead a small project and manage the deliverables effectively.
Demonstrates appropriate interpersonal skills which encourage collaboration of individuals or teams to meet objectives.
Able to be Change Agent, Reviewer or Approver of SOPs, protocols, reports or records.
Able to assist in deviation investigations, change controls and discrepancy reports.
Able to develop skill as an internal GMP auditor.
Any other tasks as and when assigned by supervisor.
Diploma with 2 to 5 years’ experience in Validation / Quality unit in the Biopharmaceutical industry
Degree from recognized institution with 1 – 3 years’ experience.
All Lonza Biologics Employees have the following responsibilities:
Quality should be the responsibility of all persons involved in Manufacturing. Adherence to cGMPs is required at all times during the manufacture of APIs.
All personnel are responsible for notifying responsible Management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc.)
All personnel should practice good sanitation and health habits.
Personnel suffering from an infectious disease or having open lesions on the exposed surface of the body should not engage in activities that could result in compromising the quality of APIs.
All personnel are required to provide support in maintaining the site safety, health and environmental programs and system.
Adherence to SHE rules and regulations is required at all times.