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Process Expert_Continuous Improvement

Novartis Pharmaceuticals Corporation

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Location: San Carlos, CA Posted Date: 4/12/2013 Position Type: Full time Job Code: 112757BR Required Education: Bachelors Degree Areas of Expertise Desired: Manufacturing/Production
Process Development
Quality Assurance
Quality Control
Validation

Description

Supports the PU in all process-specific issues, drives continuous process improvement for quality and quantity and ensures GMP requirements are met and guidelines and SOPs are followed.

Provide continuous supply of high quality products that meet technical specifications, cGMP, regulatory policies and procedures.

Root cause analysis and investigation for deviations and complaints (external and internal).

Lead and/or support of decision making for manufacturing problems.

Continuous process verification (establishes QRAs, performs process monitoring).

Provides input on process performance for APR/PQRs.

Lead and team member for quality and productivity projects.

Subject Matter Expert (SME) for inspections and audits (healthy authorities, internal inspections) according to product responsibility.

Support of launch projects; contact person for development and validation team from manufacturing.

Author and reviewer for SOPs. Ensures productivity is aligned with schedule.

Responsible for managing deviations.

Preparation and performance of operator trainings and monthly deviation CAPA training.

Initiation and implementation of change requests.

Support for KPI improvement (e. g. TPT, OAE, yield, right first time etc.)

Authoring of process and GMP risk assessments.

Ensures that manufacturing is according to GMP guidelines and within registered and validated specifications.

Establish and maintain master batch records (including bill of material).

Responsible for SOPs.

Ensure manufacturing procedures are in compliance with Health Safety and Environ-mental guidelines.

Supervision of trainees.

Requirements

Bachelors in Science or Chemical Engineering

English (fluent, oral and written)

A minimum of 10 years experience in the pharmaceutical/chemical industry.

Knowledge of a process oriented organization and self-directed culture a plus.
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