345140BR
May 11, 2022
Colombia

Job Description

21,000. That’s how many people Novartis hires globally every year. We want curious, courageous and collaborative people like you to join our inspiring environment. Here you’re given opportunities to make a genuine impact on our patient driven mission. Here you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges. Did you ever imagine how many lives could be touched by your daily work?

The people we serve need you to achieve the extraordinary. That's why at Novartis we empower you to bring your best self; we value your diversity of thought and trust your ability to make things happen.

For more information about Novartis access www.novartis.com

Your responsibilities:

Your responsibilities include, but are not limited to:
• 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.
• Coordinate implementation of quality system and procedures for the implementation of Novartis Quality Manual and quality agreements.
• 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 an effective Change Control process is in place.
• 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.
• 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.

Diversity & Inclusion / EEO

Novartis se compromete a crear un entorno de trabajo excelente e inclusivo y un equipo diverso que represente a los pacientes y las comunidades a las que servimos.

Minimum Requirements

What you’ll bring to the role:
• Fluent English Level.
• 3-5years experience in Pharma/Manufacturing sector in analytical lab in a GMP environment/equivalent.
• Good Documentation Practice and Knowledge of CAPA, GMP, Quality Assurance, Quality Management, Regulations & Guidelines.

You’ll receive:

Competitive salary, annual bonus, life insurance, home office policy, flexible working arrangements, birthday day-off, maternity and paternity leave, subsidized dining facilities, health and dental insurance, employee recognition scheme, Gympass, and virtual self-development tools.

Why consider Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. 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 ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!


Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:

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

We are an equal opportunities employer and welcome applications from all suitably qualified persons.


Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
PHARMA
Pharma QA
Colombia
Bogotá D.C
Tiempo completo
Fijo
No
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345140BR

Quality Assurance Specialist

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