Eso QAm

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.
- Your key responsibilities:

- Your responsibilities include, but not limited to:
- Lead External Suppliers Qualification process. Acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier. Provide the quality presence and in-put to Technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and goals.
- Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Pharma Quality Manual, the effective Quality Agreement that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs.
- Responsible for driving / initiating External Supplier Quality Risk assessments to be carried out for all External Suppliers. Gaps are Quality Systems to be identified with an evaluation of the associated risks. Remediation plans are to be defined and execution is to be monitored to ensure that issues are suitably addressed
- Ensure that a valid QA agreement defined in line with the requirements of the Global template is in place which clearly defines cGMP roles and responsibilities between Novartis and the External Supplier, as well as Product details and requirements.
- Request, review and process GMP documentation as defined by the Quality Agreement and Novartis SOPs. Manage the quality aspects of the relationship in accordance with the effective Quality Agreement. Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and issues.
- Responsible for coordinating and ensuring that Quality auditing of External suppliers is carried out according to the Novartis Quality Manual - maintain an annual auditing program, participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs. Ensure site readiness for regulatory inspections at External suppliers where appropriate.
- Manage critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed.
- Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance. Stability reports and PQR’s, Ensure that the External Supplier provides the required product review or the data as specified in the relevant Quality Agreement on an annual basis. Critically assess the performance of the product and process and provide the assessment to the report annually.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- What you’ll bring to the role:
- 15 years’ experience in the pharmaceutical industry, with direct experience with Pharmaceutical/Biopharmaceutical/API products. Experience in QA Operations, production, QC and/or other relevant operational areas, but must include mínimally 5 years in QA, and 3 years of management and or project management experience.
- Thorough knowledge of cGMP requirements. Strong understanding of regulatory requirements for commercial products.
- Proven track record with FDA, EMEA and other Health Authorities. Strong understanding of risk assessment and risk management fundamentals/tools.
- Strong Technical understanding of pharmaceutical processes. Team and consensus builder, with definitive and authoritative decision making ability.

Desirable:

- Bachelor or higher degree; preferred in Biochemistry, Chemistry, Microbiology or another related science
- Why Novartis?
- 766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
- We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
- We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
- Imagine what you could do here at Novartis
- Accessibility and accommodation-
**Division**
- Novartis Technical Operations

**Business Unit**
- NTO QUALITY

**Country**
- India

**Work Location**
- Hyderabad, AP

**Company/Legal Entity**
- Nov Hltcr Shared Services Ind

**Functional Area**
- Quality

**Job Type