348938BR
Jul 14, 2022
India

Job Description

1886! We have more than 130 years of experience treating patients.Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.
Lead, manage and accountable for the all lab operation activities and apply scientific/technical expertise to address all lab functioning issues for smooth operation of lab in timely manner. Coordinate with all support functions (Line function, engineering, HSE, quality, Internal/external auditors and vendors, lab planner, infrastructure and maintenance) to ensure timely deliverables of assigned projects to SDC, and contribute to overall AD strategies and goals.

YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:
• Lead and manage the lab operational activities to ensure the smooth functioning of the lab and fulfill all related tasks and responsibilities related to lab operation.
• Proactively resolve the key issues related to laboratory resource and equipment, and any other critical topics in a timely manner.
• Plan, perform and monitor all assigned activities. Ensure quality and timelines in all assigned lab activities.
• Ensure compliance to lab operations work according to appropriate SOP’s, GLP, DQP, GMP, OQM, HSE, ISEC and Novartis guidelines
• To coordinate and ensure compliance to Novartis requirements for all the utilities and facilities maintained by the service provider.
• To co-ordinate with vendors for Annual Maintenance Contracts (AMC) and external calibration activities for all equipment.
• Support all installation activities for new equipment /existing. Manage any new projects or retrofits.
• Coordinate and support the qualification, calibration and maintenance of the analytical instruments. Monitoring and control of the service providers such as Takshila, Sodexo etc.
• Installation qualification of the stability chambers , elpro sensors
• Support the facilities, calibration and qualification teams . Maintaining of Preventive Maintenance Schedules, reports, checklist etc. and ready for anytime audit readiness.
• Oversee laboratory services – ensure proper procurement (vendor selection and agreements) and maintenance (AMC & calibration) of equipment including formulation.
• Responsible for coordination of compliance activities including site assistance to other stake holders like RA, Clinical for managing internal and/or external audits and any required remediation actions.
• Adhere to the change control and deviation procedures. Initiation of quality agreement with all the service provides and ensuring its compliance

Diversity & Inclusion / EEO

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

Minimum Requirements

WHAT YOU’LL BRING TO THE ROLE:

• Ph.D. or Master’s degree in a Pharmaceutical Science/Technology or engineering. Good knowledge of English (oral and written). Desirable knowledge of site language
• Successfully demonstrated several years (mini-mum of 8 years) of directly related experience as R &D lab operation. Recognized expertise in a specific area.
• Proven track record in utilization of equipment’s /instruments for different dosage forms.
• Thorough knowledge of state-of-art instrumentation/equipment for broad field of lab Operations.
• Thorough understanding of lab operation, regulatory audits in a specific function.
• Profound lab operation and functioning skills. Ability to work in and/or lead interdisciplinary and/or cross-cultural teams.
• Strong knowledge of relevant SOP, GLP, DQP, GMP and Novartis regulations and policies.
• Strong communication skills. Strong presentation skills and scientific/technical writing skills. Advanced coaching skills.
• May require up to 15% travel

Why consider Sandoz?

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Imagine what you could do at Sandoz!

Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
SANDOZ
Product Dev SZ
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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348938BR

Technical Operation Manager

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