Job ID
390507BR
About the role
- Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance -Support exception investigations -Review and approval of production, QC, and AS and T records -MBR review -Support OpEx improvement projects Qualified Person – Executes batch release in compliance with registration -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)'9;9;9;9;9;9;9;9;9;9;9;9; To ensure the full and effective implementation of local regulationsxD; and GMP-related requirements in the Novartis/Sandoz Quality Manual. Comply with Novartis Information Security policies and rules. To comply with the confidentiality statement and disciplinary procedure. To close laboratory researches, all quality records they have in accordance with SOPs and on time. To give the approvals of finished product, validation, stability, release of raw material QC. Planning of chemical and microbiology analyzes related to production planning, preparation of all reports that are the responsibility of CCL, control, creation ofxD; methods and specifications, follow-up of KPIs, form, SOP revisions.To analyze the finished product, validation, stability, raw material samples in accordance with the methods and SOPs and to report them in accordance with the data security rules in a timely manner. To notify a relevant person about inappropriate or unexpected situations in the results of the analysis on the same day and to carry out the necessary research start. If appointed, to check the analysis record document. To use the materials properly. To comply with Novartis policies, manuals and legal regulations related to Quality, Occupational Health and Safety, Environment, Emergency Management and Business Continuity in the areasxD; and operations for which he is responsible, including sub-employer operations. To complete the additional tasks, trainings, researches given by the manager for the l
Position Title
Quality Control Specialist (Temp.)
Role Requirements
Collaborating across boundaries Functional Breadth QC/ QA in pharmaceutical ind./ biotech with environmental monitoring & cleanliness zones English Quality Control (QC) Testing Knowledge of GMP Knowledge of IT Applications & tools Quality Standards Quality Assurance
Job Type
Full Time
Country
Turkey
Work Location
Kocaeli
Functional Area
Quality
Division
SANDOZ
Business Unit
NON-NVS TSA QUALITY STO
Employment Type
Temporary
Company/Legal Entity
Sandoz Grup
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Shift Work
No
Early Talent
Yes
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