At SRG, we create meaningful connections that empower individuals and businesses to shape tomorrow’s world.
Working as part of the SRG team, you will work with our client which are Pharmaceutical or Bio-Pharmaceutical companies to ensure work quality and accuracy for our client in the Bio Pharmaceutical Industry. We are seeking an energetic and enthusiastic individual with a strong background in Validation to join the Validation Team within the Quality Group. This position will primarily contribute to the qualification of new equipment, controlled temperature unit mapping and the maintenance of a validated state for existing equipment.
Typical Job Responsibilities:
- Experience with developing, reviewing, and executing Validation lifecycle documentation (Commissioning & Qualification protocols, Validation Summary reports, Deviation Reports, Requirement traceability matrix, Periodic Reviews) in compliance with GAMP5 regulations and 21 CFR Part 11 enforced by US FDA for controlling manufacturing process and product quality in Pharmaceutical, biomedical and healthcare industries.
- Experience with qualification of Equipment (Manufacturing/Process/Laboratory), Utilities, and facility.
- Experience with temperature mapping of control temperature units using Kaye Validator and data loggers. Performing Pre- and Post- calibration of thermocouples.
- Analyze and interpret validation test data using Statistical tools like Minitab to determine whether systems or processes have met validation criteria or identify root causes of deviations.
Knowledge, Skills & Abilities
- Knowledge of system validation “life-cycle” concept.
- Capable of independent planning/organization/execution of personal workload.
- Ability to manage multiple simultaneous projects and deadlines.
- Must have excellent written communication skills to develop and write technical presentations and documentation.
- Must be capable of effectively presenting information to managers and coworkers.
- Bachelor’s degree in Life Sciences, Engineering, or related discipline with 3+ years of experience.
- Software & Databases Knowledge: Kaye Validator Software, ValPro, Vaisala vertique Vlog, LIMS.
- Previous experience in a regulated pharmaceutical, biotechnology or medical device environment a distinct plus.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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