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: Clinical Officer - SIS
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Job Description:
Key Accountability
To manage all aspects of GMP compliance and processes pertaining to both the Pilot Laboratory and Clinical supply preparation. To schedule and coordinate activities associated with usage of the pilot facility and/or clinical supply preparation. To ensure that preparation of clinical supply materials and associated documentation are completed in a compliant manner and according to project milestone requirements.
Functional Description
*Collaborate with Pharmaceutical project leaders to indentify and anticipate products needed for clinical studies, sensory and consumer research studies and registration samples in accordance with development plans.
*Order bulk/ semi-finished products and reference products from within organisation or third party manufacturers, order the required secondary packaging Schedule management. Responsible for the coordination and scheduling of Pilot Laboratory manufacturing activities and for ensuring that the equipment in the facility is qualified and ready to use by the Category Cell Teams in accordance with mutually agreed project plans.
*Compliance with GMP. Responsible for all standard operating procedures associated with the facility, the equipment installed therein, and the maintenance of such procedures and processes. Responsible for all audit preparation work needed within the facility, for self-auditing and internal audits, and will be accountable for any post-audit remediation activities and agreed action plans when inspector/auditor observations are found.
*Facility maintenance. Accountable for establishing an annual maintenance programme for all equipment in the facility and for ensuring that all equipment is correctly calibrated and qualified in terms of DQ, IQ, OQ and PQ.
*Capital budget management. Responsible for participating, as necessary, in the procurement of capital for new equipment and machinery in order to replace existing equipment or to increase in-house capability.
*Training management. Ensures that all pharmaceutical development scientists in the Cell Teams working in the facility are fully trained in the operation of the equipment, their training records and programmes are up to date and the training complies with current procedures and cGMPs.
*HSE compliance. Accountable for ensuring compliance with all health, safety and environmental regulations for Pilot Laboratory operations.
*State-of-the-Art facilities. Responsible, in consultation with pharmaceutical development teams, for maintaining the Pilot Laboratory and Clinical Room at or near a state-of-the-art level for both equipment, technologies, and processes.
*Clinical Supply Milestones. Collaborate with Category Cell Teams to plan, order, and resource the activities required for the preparation of clinical supply materials as needed to meet project milestone requirements.
*Clinical Supply Documentation. Prepare all necessary documentation required for clinical supply manufacture, packaging, and release. Ensure processes are in place for maintenance and archival of the clinical supply documentation.
*Clinical Room Inventory and Facility. Maintain an inventory of clinical supply materials. Maintain the clinical room and storage areas according to cGMP requirements. Maintain the environmental controls of the clinical storage area according to controlled room storage requirements.
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Experience Min.:
* M.Pharm – 2 year / B. Pharm -4+years or equivalent, with manufacturing approval in oral solids / powders.
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Educational Requirements
* Masters or Graduate Degree(s) in Pharmacy, or equivalent experience in pharmaceutical production, technology transfer in tablets or oral solids with requisite certification from the local authority.
Other
* Experience in or knowledge of clinical batch manufacturing, handling of pharmaceutical production equipments. Knowledge of GMPs, and validation.
* Good written and verbal communication skills, in English. Good math skills.
* 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 scientific methodology to solve difficult problems. Should be creative and show initiative.
Skill Requirements and Competencies (Shared Values)
* Highly productive and effective member of the team.
* Clearly conveys information and ideas.
* Generates innovative solutions.
* Customer focused.
* Adaptable to changes in work environments.
* General knowledge of pharmaceutical technology.
* Good ability to solve technical problems and utilize computer systems.
* Aware of conditions that affect associate safety.
* Displays initiative.
Additional Information:
Experience: 2 Years
Location: Hyderabad
Education: B.Pharm, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Division: Over The Counter
Job Type: Full Time
Employment Type: Permanent
Job ID: 87848BR
End Date: 20th Dec, 2011
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