Glims Expert, Global Dqc Coe

1 day ago

Hyderabad Telangana, India Novartis Full time

**Summary**:

- Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.

**About the Role**:
**Job Purpose**:
**Experience Required**:
Minimum 5 years of laboratory experience in a pharma industry.

**Major Accountabilities**:

- Identifies and anticipates site needs, determines what features should be implemented, and support prioritization of the backlog items.
- Identifies and anticipates site needs, determines what features should be implemented, and support prioritization of the backlog items.
- Supports continuous improvement in report templates, labels, folder templates, calculations and interfaces between the systems in scope
- Supports Business screening, PQ scripting and PQ execution.
- Supports deployment/on-boarding at new sites.
- Provides required periodic progress reports, milestone activities and communications to the program management.
- Supports establishment and maintenance of global documentation related to the systems in scope (e.g. SOPs, WIs, user guides, etc)
- Contribute to Laboratory Operations Quality System in defining and implementation of strategy and defined activities.
- Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements.

**Key Performance Indicators**:

- Metrics according to target
- Individual project completion
- Achieves agreed targets and objectives in terms of quality, time and cost
- Supports departmental objectives to implement systems according to overall program plans

**Education**:
University degree in Pharmacy, Engineering, Chemistry or equivalent Discipline

**Languages**:
Fluent in speaking / writing in English

**Experience**:

- Thorough knowledge of cGMP requirements:

- Strong understanding of regulatory requirements for commercial products.
- Technical understanding of laboratory business processes and enterprise data expertise
- Experience with Labware LIMS or other similar systems, and CSV
- Strong understanding of risk assessment and risk

management fundamentals/tools.
- Team and consensus builder, with definitive and

authoritative decision-making ability.

Division

Operations

Business Unit

Innovative Medicines

Location

India

Site

Hyderabad (Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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