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Opella · 1 month ago

Quality Projects Senior Associate

Virginia

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

Opella, the Consumer Healthcare business unit of Sanofi, is a leading player in the Over-The-Counter and Vitamins, Minerals & Supplements market. The Senior Quality Associate is responsible for providing leadership in quality-related aspects of site projects, ensuring compliance with cGMP standards while managing key stakeholder relationships across various functions.

Health CarePersonal HealthRetail

Responsibilities

Responsible for the review and approval of batch related documentation such as manufacturing formulas, instructions and specifications

Draft new/updated Bulk Specification

Execution of change actions related to system set up and routing of New Product Development (NPD)

Conduct initial setup checks for new Packaging, Bulk and FG codes

Work on change control actions related to Manufacturing Formula (MF) and Manufacturing Instruction (MI) update review and approvals

Complete MI Pilot publishing in Veeva and when ready including final version

Approve SAP status changes as per approved change control

Implement a continuous improvement culture with respect to product and process

Publish bulk specification

Perform QDOC set-up and activation

Perform SYMTEM reviews

Perform Sample Manager set-up for new testing related to NPD

Contribute to process and qualification deviations related to NPD

Ensure operations are performed in accordance with cGMP using Virginia’s standard operating procedures and within the validated state

Review and approval of operational GMP documentation as needed

Qualification

CGMP knowledgeQuality AssuranceProject ManagementRoot Cause AnalysisGMP guidelinesStakeholder ManagementCritical ThinkingLeadershipCollaborationAdaptability

Required

University degree in Engineering, Pharmacy or a science related discipline

Ideally 8-10 years' experience in a cGMP regulated environment, with TGA or PIC/s requirements knowledge and experience

Industry background in either Consumer Healthcare, Pharmaceutical or Food industry

Strong ability to build and maintain relationships with internal/external stakeholders

Strong organisation, planning and critical thinking skills. Has the ability to set and action priorities to meet objectives. Highly collaborative and is able to influence and achieve results in a team environment

Ability to work independently and as part of a team

Demonstrated Leadership capabilities

A flexible and adaptable approach

A strong dedication to the job combined with a willingness for self-development

Demonstrated good work ethic and attitude

Technically minded, with an ability to investigate manufacturing issues and root cause analysis

Good knowledge and understanding of GMP, GLP and GDP guidelines and regulations

Strong orientation for quality systems and methodologies to improve production outcomes. Understanding of manufacturing, quality control and quality assurance systems including

Ability to achieve project objectives within tight timeframes and to perform in a high-pressure environment