Job description

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA

Responsibilities:

• Design IQ/OQ/PQ and validation campaigns as well as develop, prepare and write the protocols for equipment/software validation
• Coordinate validation and IQ/OQ/PQ activities among manufacturing areas and outside contractors providing leadership, training and guidance.
• Monitor and support the execution of the protocols through training, facilitating and problem-solving activities
• Prepare or assist in the preparation of Validation Maintenance packages.
• Remains current with respect to regulatory trends and divisional issues related to their area of expertise.
• Partners with facilities, divisions, and regions to ensure knowledge sharing and successful implementation of CSV improvement initiatives
• Support the Quality System Improvement Plan (QSIP) by ensuring that activities outlined in related Quality Plans and protocols are completed, opportunities are identified, and action plans created.
• Support execution of the Computerized System Validations and Change Control associated with Data Integrity for the facility.
• Prepare, execute and document data integrity computer system validation protocols in accordance with Corporate Quality Policies, FDA, IT and ISO requirements.
• Manage the installation and qualification of multiple different pieces of manufacturing/laboratory equipment/software, working with a diverse team to achieve maximum results in minimum time.

Qualifications:

• Bachelor of Science or IT/Computer Science or Bachelor of Applied Science/Engineering (Computer Software/Systems)
• Laboratory Equipment and Computer System/Software Validation experience
• Manufacturing & Quality background
• Previous experience in a GMP environment
• Two (2) – three (3) years experience in a pharmaceutical environment
• Strong understanding of Health GMP, ISO, Medical Device Regulations

Job Types: Full-time, Temporary

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Validation: 4 years (Preferred)

Work Location: One location

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