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: Pharma Facilities Manager
Job Description:
To manage all aspects of GMP compliance and processes pertaining to both the Pilot Laboratory and Clinical supply preparation. To schedule and coordinate activites 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.
- 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 pro-cesses. 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 quali-fied 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 in-crease 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 environmen-tal 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 lev-el 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 re-quirements.
Candidate Profile:
A Master’s degree in Chemistry/Pharmaceutics/Pharmacy or related scientific field is required. India Fluent written and spoken English required 10-12 years Pharmaceutical industry experience is required with increasing levels of responsibility and including significant experience leading activites in a GMP environment.
Additional Information:
Job ID: 139381BR
Experience: 10-12
Location: Andhra Pradesh-Hyderabad
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Development & Medical
End Date: 30th April, 2014
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