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Technical Operation Manager Full-time Job

2 weeks ago Medical & Healthcare Hyderabad   16 views
Job Details

Job Title: 297380BR

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.

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. Adhere to the change control and deviation procedures.
• 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. In addition, to coordinate with vendors for Annual Maintenance Contracts (AMC) and external calibration activities for all equipment.
• Manage any new projects or retrofits. Support all installation activities for new equipment /existing. Coordinate and support the qualification, calibration and maintenance of the analytical instruments
• Monitoring and control of the service providers such as Takshila, Sodexo etc. Initiation of quality agreement with all the service provides and ensuring its compliance
• 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 stakeholders like RA, Clinical for managing internal and/or external audits and any required remediation actions.

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 (minimum 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. Strong knowledge of relevant SOP, GLP, DQP, GMP and Novartis regulations and policies.
• Ability to work in and/or lead interdisciplinary and/or cross-cultural teams.
• 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.


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Company Description
Novartis was created in 1996 through a merger of Ciba-Geigy and Sandoz. Novartis and its predecessor companies trace roots back more than 250 years, with a rich history of developing innovative products. From beginnings in the production of synthetic fabric dyes, the companies that eventually became Novartis branched out into producing chemicals and ultimately pharmaceuticals.