Method and Equipment Validation Analyst
- Experience Level
- Experienced (non-manager)
International Pharmaceutical Manufacturer seeks an experienced Validation Analyst.
About the role:
To contribute to the Quality Laboratory function, through competently taking, testing and approving samples in accordance with departmental Standard Operating Procedures, Company Policies, and to the principles of GMP. This role provides greater support for processing of laboratory records and reports and will undertake training of technical staff.
Duties may include:
- To perform a wide variety of Method and Equipment Validation activities in accordance with Standard Operating Procedures, protocols, policies and GMP.
- Responsible for preparing reagents, standards and control samples in support of validation work.
- To promptly report any validation deviations, out-of-specification / limits results.
- Raise validation deviations in the quality system, leading minor investigations and ensuring effective implementation of identified CAPAs. Support major validation deviations.
- Support controlled changes within the department
- To read, collate, analyse, report and archive data using defined documentation and computer systems.
- To ensure equipment used is clean, calibrated and maintained. Perform system suitability checks where required
- To assist with the calibration or validation of laboratory equipment and automated systems.
- Ensure required stock available for validation work, ordering quantities required in advance of initiation of work.
- Preparation of validation life cycle documentation.
- To operate a variety of instrumentation and computer software packages intended for data analysis, collation and other related applications (e.g. LIMS).
- To make recommendations and perform updates of departmental documentation (e.g. SOPs).
- Undertaking administrative activities.
- To organise own assigned working activities. To be responsible for reporting issues or delays to next line management.
- Perform training of Level I + II Analysts
- To identify continuous improvement initiatives.
- To attend meetings as required.
- Perform review of basic laboratory documentation
- To participate in the receipt of audits from internal and external sources, ensuring own work area is audit ready at all times.
- To adhere to record and data integrity requirements, as per Company polices.
- To perform any other aspects of laboratory testing and support the objectives of the department as required.
- Responsible for ensuring own training record is completed and up to date
Skills and experience:
- Method Validation and Method Transfer experience
- Equipment Validation experience
- Experience of working in a laboratory environment
- Understanding of GMP/GLP.
- Good knowledge of the pharmaceutical industry, both within a laboratory and across pharmaceutical processes.
- Knowledge of laboratory SOPs and ability to revise and write new procedures.
- Understanding of knowledge of laboratory operations and practical work.
- Knowledge of stock control and budgeting in own area
- Experience is using analytical equipment and pipettes
- Experience writing reports
- Experience in quality records and investigations