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Executive QA Onco

2 weeks ago

Mumbai, India Novartis Full time

With 64 manufacturing sites in 26 countries, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry.
- Position Purpose:

- Highly skilled & experienced Quality professional who contributes by supporting of QMS & Oversite of GMP activities at Oncology site
- Your key responsibilities:

- Your responsibilities include, but are not limited to:
- Review of Equipment/ System Qualification documents (URS, DQ, IQ, OPQ etc.). Review of key validation documents for Computerized Systems and ensure that the expectation of 21 CFR Part 11 are satisfied implemented through adequate review.
- Review for distribution and monitoring of annual schedule for periodic review for need of re-qualification of Equipment/ System to all departments. To archive and maintain qualification documents.
- Preparation, review and/or approval of Quality Risk Assessment.. Periodic overview of GMP activities. Review of calibration and preventive maintenance activities of manufacturing/QC equipment. Review/ Approve of SOP and documents related to equipment/system qualification.
- Periodically supervise the corrective and preventive action and to expedite for closure and extension of corrective and preventive actions within the stipulated timeline. QA oversight on QC, Production, warehouse, engineering department, Utility, Service Floor, calibration and maintenance activities etc.
- To review/ approve periodic review reports for need of re-qualification of equipment/system. Issuance of GMP documents. Release/Rejection of SFG in SAP
- Perform periodic user management of standalone and network systems as an Administrator for Laboratory & Production instruments/Equipment’s. Review of executed batch manufacturing record (BMR), Batch packing records (BPR) and Electronic batch record (EBR). Ensure compliance with Novartis / Sandoz regulation and SOP / Pharmacopoeia/Group requirements / local and International authorities.
- Maintain confidentiality and ensure safe custody and efficient handling of company document / material. Perform any other task that may be assigned for running of the company as per latest quality standard and Novartis Corporate Guidelines.
- Ensure efficient inter and intra department communications. Any other responsibility that may be assigned by supervisor/Manager from time to time. Follow Quality behaviors.

**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:
- B. Pharm/M. Pharm/M.Sc. from reputed institute
- 5-10 years, preferably in oral solid Dosage (Experience in Oncology would be preferred)
- Collaborating across boundaries Functional Breadth with min 3-5 years’ experience in Quality assurance of Pharma/Manufacturing sector such as analytical lab, Manufacturing, engineering in a GMP environment/equivalent.
- Qualification activities, Vendor management Investigation, QMS, Audit, Quality Control & Other GMP activities.
- Quality decision making, Knowledge of IT Applications & tools, Knowledge of TQM and related industry. GxP standards and processes

Why Sandoz?
- 500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
- How will we do this? 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 Sandoz
- Commitment to Diversity & Inclusion:

- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.**Division**
- Novartis Technical Operations

**Business Unit**
- QUALITY

**Country**
- India

**Work Location**
- Mumbai

**Company/Legal Entity**
- Sdz Pvt Ind

**Functional Area**
- Quality

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No