Quality Assurance Lead Consultant Jobs

Manage material disposition for commercial and clinical trial materials.

Manage the review of product release and stability data.

Possess a scientific degree (BS) and have at least 5-8+ years of experience in the pharmaceutical/biotech industry.

5+ years of experience in Quality Assurance.

Preferred experience with topical and liquid dosage forms.

Provide quality oversight for contract manufacturing operations of drug substance and drug product, both for commercial and clinical trial materials.

Verbatim Pharma are currently working with a global pharmaceutical company who are looking for a Quality Manager.

I am looking for someone with experience in -

Interim Quality Assurance Consultant Position

Host internal and external audits

Working in a GMP/GDP environment

Some of the key responsibility's for this position are -

G. Three years of experience with Application Lifecycle Management, tracking bug fixes, test results, and release management.

*Candidates chosen for an interview will meet the Education, General Experience and Specialized Experience requirements.

A. Two years of experience with establishing and executing automated test procedures.

B. Three years of software testing experience (integration and acceptance) on multiple projects.

D. Three years of experience testing database interfaces in a multi release project environment.

A. Determine the resources required for quality control.

Experience in quality assurance, quality improvement, or risk management within a healthcare setting.

Strong knowledge of healthcare regulations, standards, and best practices (e.g., HIPAA, CMS Conditions of Participation).

Excellent analytical skills, with the ability to collect and interpret data, identify trends, and make evidence-based recommendations.

Effective communication and interpersonal skills to collaborate with diverse stakeholders and present information clearly and concisely.

Problem-solving and critical thinking abilities to identify issues, root causes, and innovative solutions.

Ability to manage multiple priorities, projects, and deadlines effectively.

Assist with the preparation of quarterly reports detailing the KYC reviews for senior management.

Perform Quality Assurance reviews of customer KYC files for new account openings, periodic-refresh of existing customers, off-boarded customers, and trigger-based events.

Be responsible for documenting file reviews and maintaining an internal tracking log for items requiring remediation.

Identify trends, areas of improvement and potential training opportunities for the KYC team.

This analyst will also be utilized for special projects as needed especially with the new TOM implementation.

Maintain a thorough knowledge of appropriate standard operating procedures and applicable regulatory requirements and guidance documents.

· A minimum of 5 years’ experience in Medical Device industry.

· Prior experience with companies dealing with 483 warning letters.

· Excellent Verbal and written communication skills.

· Analytical skills and focus on detail.

Closing of urgent CAPA’s in line with standards while maintaining a high level of quality throughout

Lead and manage construction administration deliverables on complex projects and tasks

Ensure quality of products and deliverables meet project and client requirements

Coordinate and manage project teams and small to mid-size projects

Bachelor’s degree or equivalent years of experience

7 to 10 years of experience

Experience with using required technical software and applications