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: Quality Assurance - Associate Manager - DS&E
Job Description:
Provide pharmacovigilance related quality and compliance oversight, training and continuous improvement oppor-tunities to DS&E and other business partners. Through risk-based audits and assessments of pharmacovigilance systems and operations, identify quality and regulatory compliance issues and assist with remediation.
Major Activities (Describe main activities)
1. Provide input to team to help develop an effective risk-based audit strategy and programme.
2. Identify and communicate regulatory compliance issues to DS&E QA management. Provide assistance with the remediation of compliance concerns and provide on-going project support and governance, as assigned.
3. Support initiatives focused on quality improvement and compliance quality initiatives for in-spection readiness.
4. Assist audit team with the planning, performance, conduct, follow-up and documentation of global quality regulatory compliance audits and assessments of pharmacovigilance and safety reporting practices within Novartis Pharma.
5. Review and evaluate proposed corrective and preventative action plans (CAPA) in collabora-tion with the responsible business unit. Monitor and track status of corrective and preventative actions to ensure that the issues are adequately addressed and completed. Contribute to closure of audits through close collaboration with involved business units and partners.
6. Provide support to Health Authority (HA) PV inspections. Provide input to CAPA to ensure quality, consistency and appropriateness of commitments.
7. Assist in the identification, development, implementation and conduct of appropriate training for business partners.
Candidate Profile:
Education (minimum/desirable):Post Graduate in Life Sciences/ Pharmaceutical
Languages: English fluency at operational and functional
Experience/Professional requirement: Minimum of 3 years PV/clinical/industry/health authority experience, auditing experience a plus;
* 20% travel;
* Ability to manage and objectively evaluate compliance issues;
* Ability to multi-task and maintain a modest level of independence with respect to decision making and problem solving;
* Experience with Health Authority inspections and interaction a plus;
* Excellent verbal and written communication, organizational and interpersonal skills;
* Quality and compliance mindset;
* Excellent computer skills, including Excel, Word, etc;
* Good knowledge of applicable PV, GCP and GxP regulations, guidelines, policies and procedures;
* Good knowledge of computer validation and Part 11 requirements;
* Ability to operate successfully in various cultural environments;
* Auditor certification a plus.
Additional Information:
Location: Hyderabad
Education: M.Pharm, M.Sc, Ph.D
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Division: pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 95152BR
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