Job Description
Support site commissioning and qualification, which includes but is not limited to the following:
equipment, utilities, cleaning, process, assay qualifications. Ensuring the timely development,
execution, and coordination of all validation activities pertaining to facility, equipment, and
process in compliance with Quality System requirements, site procedures and regulatory
requirements. This role will develop validation and Quality System documentation (e.g.,
IQ/OQ/PQ/SOP/Change Controls/Deviations/CAPAs etc.). This role will organize all validation
activities ensuring project completion per schedule requirements.
Responsibilities :
- Maintain the Company’s compliance with established PLS Standard Operating Procedures and specifications and Current Good Manufacturing Practices.
- Write, execute and coordinate commissioning, qualification and validation protocol testing.
- Compile relevant commissioning/qualification/validation study data and generate summary reports to document the results of the studies.
- Aid in troubleshooting/impact assessment for atypical conditions during studies/ validations.
- Assist in the maintenance and development of any existing validation programs to ensure continued compliance with regulatory requirements.
- Provide scientific rationale/strategy for studies of new or modified GMP equipment and processes.
- Ensure all aspects of validation and qualification adhere to site and corporate policies and procedures, including safety and training.
- Review all errors, protocol deviations, and comments with the respective user department Management and QA and resolve discrepancies.
- Manage responsibilities and workload to assure accurate and timely data and reports.
- Initiate Change Controls in order to support validations in accordance with QMS processes.
- Perform investigations as needed to support QMS Deviation/CAPA processes.
- Implement Corrective/Preventive Actions related QMS CAPA processes which may require validation activities.
- Review completed validation, PM, and calibration documentation for accuracy and GMP compliance.
- Comply with FDA guidelines, Site and Corporate Policies for Data Integrity.
- Other duties as assigned.
Requirement :
- Ability to manage and plan multiple projects.
- Knowledge of cGMP’s, GDP’s and regulatory requirements as they related to qualification and validation activities (IQ/OQ/PQ).
- Possess a working knowledge of Microsoft Word, Windows, Excel, Power Point, and Statistical tools such as Minitab/Jmp.
- Must possess excellent analytical skills, good problem-solving technique and data analysis skills using Excel.
- Employee must have excellent communication skills, both written and verbal
- Employee must be collaborative when working with groups.
- Attention to detail is required.
Career Level
Validation / Validation Specialist
Job Specializations
Specialist / Validation
Qualification
Technical discipline (sciences, engineering) or
related field preferred
Year of Experience
6 to 8 years of experience.
