Sr. CQV Review Pharmaceutical Manufacturing 3140/3141/3142DB

Who are we:

Looking for an exciting opportunity at a fast growing, employee-oriented company?Verista’s 500+ experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Whether it’s compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.

Verista’s experts include SMEs across the spectrum of pharma, medical devices and biotech industries. As a result, we’re uniquely capable of offering transformative, integrated solutions, new perspectives, and consistent results.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable our clients to improve the quality of patient healthcare worldwide. Our talented and dedicated professionals are committed to making an impact every day.

We deliver solutions that are right the first time.

Typical Project Accountabilities Include:

• Provide technical CQV (commissioning, qualification, and verification) expertise on large capital projects involving new or modified equipment, facilities, and utilities ensuring CQV aspects are delivered consistently and efficiently. Includes authoring and executing documents such as URS, System boundary definition, Risk Assessment, Traceability matrices, Design Qualification, Start Up and Debug documentation, commissioning documents, including FAT and SAT, IQ/OQ/PQ, Turnover documentation.
• Author and execute technical commissioning and qualification documentation for complex, automated equipment, and processes, in accordance with client’s quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 210, 211 and 820 level standards which apply to the equipment and product being validated) and national/international standards.
• Verify system drawings including ability to review and as-build P&IDs and I&C drawings as well as verifying electrical schematics with electrical engineering support.
• Manage and work collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Maintain clear and detailed records of qualification and change control activities for future compliance audits.
• Project assignments will vary by customer requirements for specific defined deliverables based on project needs and scope.

THIS 12 MONTH ASSIGNMENT IN THE DURHAM, NC AREA WILL REQUIRE A CANDIDATE WHO CAN BE ONSITE AT LEAST 3 DAYS PER WEEK IN DURHAM, NC.

THE SPECIFIC PROJECT ASSIGNMENT WILL BE TO PERFORM THE FOLLOWING;

The focus for the position includes all aspects of Quality oversight for drug product, drug substance, media preparation, and sterile supply.

Position Responsibilities:

Reporting to the Quality Assurance Organization, will independently manage project assignments.

Ensure all aspects of the project proceed in compliance with cGMP, regulations, and the Clien's Quality Management System.

Focusing on areas such as Commissioning, Qualification and Compliance covering Manufacturing Equipment (isolator, restricted access barrier, incubator, washer, autoclave, formulation vessel, lyophilizer, etc.).

Provide QA support including critical / constructive review and approval of GMP documentation such as Quality Agreements, Quality Risk Assessments, URS, FAT, IQ, OQ and other technical documents to meet schedule milestones.

Review and approval of master batch records, executed records, technical protocols, investigations, change controls, SOPs, validation protocols, technical reports.

Requirements

• A minimum of a bachelor’s degree in an Engineering or Scientific degree

Preferred:

• Bachelor's and/or Master’s Degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline. Will consider Associate degree if they have 7+years of relevant experience.

• Experience with review and approval of URS, FAT, IQ, OQ, PQ for manufacturing equipment, facilities and utilities..

• GMP quality experience with biological drug substance or drug product.

• GMP experience with qualification of equipment.

• Experience with Quality Risk Management.

• Project Management experience in a highly regulated industry.

• Experience with Kneat, SAP, Trackwise and/or GLIMS

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Benefits

Because employees are the key to our success, Verista offers strong benefits and incentives including: