Quality Validation Specialist

4 weeks ago

Coventry, United States Germer International Full time

Key Responsibilities Include

:

QA lead for qualification of process equipment, utilities, computer systems, and lab equipment.

Review and approve protocols pre-execution

Review and approve executed protocols, summary reports, and collected evidence

Assess qualification effort in relation to the final reports and conclusions made

Perform periodic review of systems, equipment, utilities, and storage areas as part of our periodic requalification evaluation program.

Monitor requalification due dates through use of a tracking spreadsheet

Assess procedures, change controls, deviations, maintenance, calibrations, and service agreements in relation to maintaining the qualifies state of systems, equipment, or utilities.

Author reports documenting assessments

Review and assess temperature mapping studies for lab, stability, and material storage areas.

Review and assist in shipping validation for late phase/commercial products.

QA lead for process and cleaning validation

Review and approve protocols pre-execution

Review and approve executed protocols, summary reports, and collected evidence

Assess validation documentation in relation to actions performed and conclusions made

Initiate changes toward continuous improvement of site policies and procedures focusing on qualification and validation activities.

Review and assess relevant change controls and deviations for impacts to qualified state.

Develop effective CAPAs for investigations related to qualification/validation.

Represent QA for qualification and validation related cross functional project teams.

Assist QA in regulatory inspections and the site internal audit program.

Education and Experience Requirements

:

Bachelors degree with 6 plus years of experience associated with validation, manufacturing, or facilities environments

Prior experience in QMS systems such as deviations, CAPAs, change controls

Prior experience authoring reports and procedures

Prior experience in audits and inspections

Excellent communication skills

Strong attention to details

Additional beneficial experiences include:

Knowledge of GAMP 5 and 21CFR Part 11 for computer systems

Knowledge of ICH Q9, Quality Risk Management

Knowledge of EMA, MHRA, and Health Canada regulations

Knowledge of lifecycle approach to cleaning and process validation

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