QA Operations Specialist, Batch Review

Job description

Job Description

The QA Operations Specialist, Batch Review, will report to the QA Coorindator, Batch Review at Novartis BioProduction Operations Singapore.

Job Purpose
This role is responsible for the establishment, maintenance and overall compliance of the manufacturing processes in the BioProduction Operations Singapore facility.

Key Responsibilities
• Strive to constantly improve systems and practices in Documentation and Training with respect to achieving compliance, reducing waste and improving efficiencies
• Ensure all health and safety procedures are followed and maintain complete compliance to all mandatory trainings
• Ensure that during the project phase all activities related to establishing manufacturing processes for Drug Substance comply with cGMP and applicable regulations and Novartis Quality Manual
• Ensure that all required Quality procedures are in place to start up the manufacturing processes
• Write, Review or approve the GMP procedures related to his/ her activities
• Support establishment of and review and/or approve Master Batch Records
• Participate as a representative of the Operational QA in project teams concerning equipment, cleaning and process validation
• Maintain and update the different Quality systems and verify that they are applied
• Participate in the general QA activities and assist in the different areas of the QA function (Compliance /Release/Change control)
• Manage quality issues and investigations (e.g. deviations; trends, OOS) with the respective departments
• Participate in the internal and/or external audits program
• Interpret current Good Manufacturing Practices (cGMPs) for the site and evaluates Novartis procedures relative to FDA / EU and industry standards. Recommends changes where appropriate
• Participate in the preparation of the site for FDA / EU pre-approval inspections
• Responsible for achieving QA yearly objectives, and adhering to budgets.
Position Title

QA Operations Specialist, Batch Review

Desired profile

Minimum requirements

• Masters or Degree in Natural Sciences (Biotech preferred), Pharmacy, Biotechnology, Microbiology, Chemistry or related experience (sterile manufacturing)
• Minimum 3 years of related experience or equivalent
• Thorough knowledge of Good Manufacturing Practices
• Familiarity with microbial products and manufacturing processes highly desirable
• Ability of work cross-functionally
Job Type

Full Time
Company/Legal Entity

Singapore Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd
Country

Singapore
Work Location

Singapore
Functional Area

Quality
Division

Novartis Technical Operations
Business Unit

NTO QUALITY
Employment Type

Regular
Sourcing Statement

You are applying to be part of the Novartis Talent Pool. We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV.