QC Analytical Equipment Support Spec

Job description

Job Description

• Execute maintenance and service programs consistent with cGMPs, industry best practices, and internal Novartis Policies and Requirements. • Create and update operation and maintenance procedures for equipment. • Create documents (SOPs, Gap Assessments, Risk Assessments, etc) to support the Data Integrity and Information Security and Risk Management programs. • Knowledge of appropriate GMP quality systems. • Perform review of GMP audit trail for computerized systems in the lab. • Manage security of GMP systems in the lab including managing user access and periodic data backup. • Manage change control for new equipment, equipment repair or software upgrades. • Support qualification and re-qualification activities for laboratory equipment • Independently schedule and prioritize workload to ensure all equipment activities are per-formed in a timely manner. • Participate and perform laboratory investigations and deviations. • Perform other duties as assigned.
Posting Title

QC Analytical Equipment Support Spec

Desired profile

Minimum requirements

BS/MS or equivalent in chemical or Biochemical engineering, Microbiology, Biotechnology, Biochemistry or other Life Science-related field Fluent in speaking / writing in English 5+ years of experience in the pharmaceutical industry (quality assurance, quality control, production) or a directly related field Min 2-3 years experience with analytical equipment maintenance Demonstrated knowledge and skill in multiple analytical and microbiological techniques. Knowledgeable in ICH and FDA/EMA GMP requirements. Ability to plan, prioritize and execute multiple tasks simultaneously under tight deadlines.
Job Type

Full Time
Country

USA
Work Location

Morris Plains
Functional Area

Quality
Division

Novartis Technical Operations
Business Unit

NTO BTDM
Employment Type

Regular
Company/Legal Entity

Novartis Pharmaceuticals
EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.