Povzetek
About the Role
Major accountabilities:
· Assure the respect of the GMPs and Health Authorities requirements at local level.
· Contribute to maintain the local quality system as per GMPs and corporate guidelines.
· Redaction and review of SOPs, records, protocols and reports according to GMPs, National/ Corporate Guidelines and health authorities’ requirements.
· Registration and archive of the documentation at local level.
· Manage the GMP logbooks (distribution, archiving and revision).
· Collaborate in the management of Annual Product Reviews (redaction and review).
· Manage of training records, execution at local level of staff GMP training and redaction of the Training Annual Plan.
· Support the Quality Site Head during escalation case in case of critical issues occurred.
· Participate to the self-inspections as per approved annual plan and to the external audits (Health Authorities, Certified Bodies, Supplier).
· Support in management and redaction of Out of Specifications, System Suitability Test failure, Out of Trend, Deviations, CAPA, Change Controls, Complaints according to cGMP and reference SOPs.
· Collaborate in the annual suppliers’ qualification in accordance with related SOPs.
· Fill in the KQIs files.
· Prepare and print the batch documentation.
· Support the QPs in the batch record review.
· Support at local level the QA Department:
o in assuring the execution of qualification, maintenance, calibration and revalidation programs;
o in managing the external inspections follow up;
to follow the training annual plan.
Key performance indicators:
Inspection management (no critical observations during Health Authorities inspections).
Completion of all relevant quality records within applicable time frame, with measured overdues.
Minimum Requirements:
Work Experience:
- Functional Breadth.
- QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.
- Collaborating across boundaries.
- cleanliness zones.
Skills:
- Continuous Learning.
- Dealing With Ambiguity.
- Gmp Procedures.
- Qa (Quality Assurance).
- Quality Control (Qc) Testing.
- Quality Standards.
- Self Awareness.
- Technological Expertise.
- Technological Intelligence.
Languages :
- English.
Education: Pharmaceuticals, Chemical or biological degree
Languages: Fluent English verbally and in writing
Experiences:
- 1+ years of experience in a Quality dept.
- Strong affinity with and awareness of quality issues
- Good organizational skills including attention to details
- Knowledge of quality system (GMP)
- Basic knowledge of regulatory requirements
- Shows the appropriate sense of urgency around given tasks
- Work in team
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