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Opportunity for Master’s degree in Chemistry/Pharmaceutics/Pharmacy as COMPLIANCE MANAGER in Novartis

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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: COMPLIANCE MANAGER

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Job Description
To provide overall management for all aspects of cGMP compliance, procedures and processes pertaining to the GPD laboratories at the site, including Analytical, Pharmaceutical, and Stability Laboratories. To manage equipment procurement, qualification, calibration, and preventative maintenance activities. GMP Processes and Procedures. Responsible for maintenance and coordination of cGMP processes and procedures for the GPD laboratories. Collaborates closely with R&D Quality Assurance to monitor and address cGMP compliance within the GPD laboratories. Equipment/Facility Maintenance. Coordinates the purchase and qualification of new equip-ment and software in the GPD laboratories. Oversees the scheduled calibration and on-going maintenance program for equipment in the GPD laboratories. Computer Software Maintenance. Ensures that computer software applications for the laboratories remain in a validated state and are tracked appropriately according to compliance requirements. Training management. Ensures that all associates in the working in the facility are fully trained on Quality & compliance, their training records and programs are up to date and the training complies with current procedures and cGMPs. Quality/Compliance. Monitors closure of on-going CAPA’s, deviations, change controls, and OOS/OOE’s in TrackWise system. Responsible for all audit preparation work needed within the facility, for self-auditing and in-ternal audits, and will be accountable for any post-audit remediation activities and agreed ac-tion plans when inspector/auditor observations are found. 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. HSE compliance. Accountable for ensuring compliance with all health, safety and environ-mental regulations for the GPD Laboratories. State-of-the-Art facilities. Responsible, in consultation with the development teams, for maintaining the GPD Laboratories at or near a state-of-the-art level for equipment, technolo-gies, and processes.

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Candidate Profile:
A Master’s degree in Chemistry/Pharmaceutics/Pharmacy or related scientific field is required. English 8 -10 years Pharmaceutical industry experience is required with increasing levels of responsibility and including significant experience leading activities in a GMP environment.

Additional Information:
Job ID: 126517BR

Experience: 8-10
Location:
Andhra Pradesh-Hyderabad
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: CR
End Date: 11th Sep, 2013

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