Apqr Specialist

Job ID- 380217BR- Aug 16, 2023- Mexico**Job Description**:

- 2023 will see Sandoz become a standalone organization As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength Those joining Sandoz in the coming months will help shape the future of the company, its growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impactThis is one such role
- Are you ready to make a difference?
- 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 & Inclusion / EEO**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve._

**Minimum Requirements**:

- Collaborating across boundaries
- Functional Breadth
- Participating in volunteer / community projects
- English
- Regulations & Guidelines
- Knowledge of CAPA
- Good Documentation Practice
- Quality Management
- Quality Assurance

ORBIT
What you’ll bring to the role:
You’ll receive: (not mandatory)Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.
Why Sandoz?500 million patients were touched by Sandoz generic and biosimilar medicines in 2021and 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.How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiouslytackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never tryingImagine what you could achievehere at Sandoz

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