Job Description

Job Responsibilities:

• Perform qualification of QC laboratory equipment in accordance with established equipment qualification policies, plans, and procedures.
• Coordinate with laboratory personnel to define equipment qualification requirements and acceptance criteria.
• Author, review, and execute equipment qualification protocols and related documentation.
• Coordinate equipment qualification activities with equipment vendors and internal support organizations.
• Ensure qualification activities are performed in compliance with current cGMP regulations and applicable quality standards.
• Review qualification documentation for accuracy, completeness, and compliance.
• Identify business, quality, operational, and compliance gaps associated with laboratory equipment and qualification activities.
• Support resolution of qualification-related issues and coordinate appropriate corrective actions.
• Maintain accurate and timely validation and qualification records.
• Sign and approve documentation for activities within authorized responsibilities and applicable company procedures.
• Work closely with QC laboratory personnel and cross-functional stakeholders to ensure equipment is qualified and ready for intended use.
• Support continuous improvement initiatives that enhance laboratory compliance, operational efficiency, and cost effectiveness.
• Assist with scheduling and prioritizing qualification activities to meet business objectives.
• Communicate qualification status, issues, risks, and required actions to appropriate stakeholders.
• Provide technical and operational support to QC laboratory activities as assigned.
• Perform additional validation, qualification, and laboratory support duties as requested by management.

Skills:

• cGMP Regulations
• Equipment Qualification
• Equipment Validation
• QC Laboratory Validation
• Validation Protocols
• Qualification Protocol Authoring
• Protocol Execution
• Validation Documentation
• Pharmaceutical / Biopharmaceutical Manufacturing
• Quality Compliance
• GMP Documentation
• Quality Systems
• Compliance Gap Identification
• Continuous Improvement
• Laboratory Equipment
• Vendor Coordination
• Cross-Functional Collaboration
• Technical Documentation
• Problem Solving
• Project Coordination
• Scheduling and Prioritization
• Verbal and Written Communication

Education/Experience:

• Bachelor's degree (BS/BA), preferably in a relevant scientific discipline.
• Experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.
• Knowledge of current cGMP regulations or equivalent applicable regulations.
• Minimum 2 years of experience in validation or equipment qualification is desired.
• Experience supporting QC laboratory equipment qualification activities preferred.
• Ability to author, review, execute, and maintain equipment qualification documentation.
• Strong understanding of quality and compliance requirements in a regulated laboratory environment.
• Ability to make sound decisions regarding scheduling, priorities, and qualification activities.
• Flexible approach to problem-solving and ability to provide direction when required.
• Strong verbal and written communication skills with the ability to effectively influence stakeholders at different organizational levels.
• Ability to build trust-based and effective working relationships with laboratory personnel, vendors, and cross-functional teams.
• Strategic thinking with the ability to translate objectives into actionable plans.
• Strong ownership, accountability, and results-oriented approach.

Job Tags

Similar Jobs