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Novartis Invites Associate Site Services (PD)

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A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post: Associate Site Services (PD)

Job Description:
Key Accountability
Deliver Calibrations, Maintenances, Qualifications and supports purchase activities as per the project requirements which meets the needs with expected quality, timing and budget. To ensure compliance and local regulatory requirements to support the project development activities in Thane.

Functional Description
• To prepare and submit documents, get necessary approvals from Local regulatory bodies to support the product development activities on site.
• To perform the calibration and preventive maintenance of all pharmaceutical instruments/equipments as per GLP Standards.
• To co-ordinate with vendors for all Annual Maintenance Contracts (AMC) and external calibration activities for all instruments/equipments.
• Preparation and execution of all installation activities for new equipments along with any requalification/validation for existing instruments as part of the compliance requirement.
• To manage routine lab activities like Environmental monitoring of lab, like daily temperature and Humidity check, raw material procurement / store management, Glassware procurement/maintenance, Waste Management and Water System Management for smooth functioning of Laboratory activities.
• To ensure lab safety, first aid maintenance, routine checks of safety equipments, maintenance of Gas cylinders, ETP operations and Management.

• Prepares SOPs for pharmaceutical development equipments and instruments as and when required.
• To co-ordinate for all purchases and purchase related activities like preparation of rate contracts, capex items, generation of Material Requisition Forms and its approval, procurement of quotations, receipt and verification of received materials for physical damage/pricing as per agreed rate contracts.
• Participates in the upkeep of laboratory in order to meet GMP and Novartis standards.
• Manage site administrative activities and supports IT systems development.
• To fulfill additional responsibilities given by the manager as and when needed.

Candidate Profile:
Educational Requirements
• Degree(s) in Pharmacy or related disciplines or equivalent experience.
Experience Min.:
M.Sc./M.Pharm.-1+years
B.Sc./B.Pharm.-2+years

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Other
• Experience in or knowledge of pharmaceutical formulations, Process optimization and Tech transfers, Local and international regulatory compliances (GMPs, USFDA).
• Good written and verbal communication skills, in English.
• Ability to think logically and draw valid conclusions.
• At more senior levels positions require an advanced degree or equivalent experience and knowledge, and ability to apply technical knowledge to solve difficult problems. Should be creative and shows initiative.

Key Distinguishing Responsibilities
• Ensures compliances as per the local regulatory bodies and Novartis standards.
• Uses technical knowledge to solve problems with instrumentation or equipments of moderate complexity.
• Manages Preventive Maintenance and Calibration of pharmaceutical instruments and equipments.
• Participates in implementation of new instruments, software’s, systems and instruments and equipments.
• Follows GMPs, SOPs, safety requirements, and other applicable regulations.

Additional Information:
Experience: 2+ Years
Location:
Thane
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area:
F&D
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID:
80487BR
End Date: 30th Sept., 2011

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