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Complaints Specialist
hace 3 semanas
#Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our ‘new’ Sandoz
Your key responsibilities:
- Ensure that Change requests, are managed according to the Novartis SOPs from receipt, through to the implementation and closure.
- Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, Follow up the corrective actions. Archive relative documentations. & Coordinate implementation of quality system and procedures for the implementation of Novartis Quality Manual and quality agreements.
- Ensure that all aspects of the handling and distribution of pharmaceutical products in the country comply with the requirements of the Novartis Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements.
- Ensure that a local Quality System and Standard Operating Procedures are in place for all cGMP/GDP related activities and that compliance with cGMP/GDP regulations is maintained through training and internal audits.
- Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country.
- Establish a good working relationship with the Supply Chain Management (SCM), DRA and Medical departments. & Ensure that coordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance.
- Ensure that all incoming drug products are inspected prior to release to the market in accordance with the current in place procedures, registered specifications and with local/international regulations.
- Ensure that an effective Change Control process is in place. & Manage complaints, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures. Support / participate in NEM cases as required.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Diversity and Inclusion
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
Minimum Requirements
- Operations Management and Execution
- Collaborating across boundaries
- Functional Breadth
- Participating in volunteer / community projects
- English Regulations & Guidelines
- Knowledge of CAPA
- Good Documentation Practice
- Quality Management
- Quality Assurance
You’ll receive:
Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
The future is ours to shape
- Division
- SANDOZ
- Business Unit
- Quality STO
- Location
- Mexico
- Site
- Ciudad de México
- Company/Legal Entity
- SDZ MEX
- Functional Area
- Quality
- Job Type
- Full Time
- Employment Type
- Regular
- Shift Work
- No
