Job Details
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Job Description
About the Job
Job Purpose:
- Prepare and execute cleaning, process and packaging validation, and equipment qualification plans and protocols.
- Write Final Summary Reports that summarize executed qualifications/validations. Assist in the development, coordination, and execution of qualifications/validation protocols for systems governed by GMP as applicable in the pharmaceutical industry.
- Coordinates validation related activities in regards to equipment and processes being deployed in GMP environments.
Major Responsibilities:
- Develop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities/utilities supporting these operations.
- Develop and execute process validation protocols for all manufacturing and packaging processes of commercial products
- Develop and execute cleaning validation/verification protocols for all commercial manufacturing, processing, and packaging equipment.
- Perform proper and timely sampling of in-process/intermediate products, finished products, rinse water and surface swabbing for testing as outlined by validation/qualification protocols.
- Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.
- Draw conclusions from data, observations, deviation/exception and investigation as to whether a process is considered valid.
- Write summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies.
- Maintain protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner.
- Ensure protocols, verifications, validation plans and summary reports generated during validation/ qualification activities are stored according to the procedure.
- Planning and execution of the calibration master plan and Validation Master Plan.
- Responsible for compliance with a quality integrated system for quality, environment, health, and safety in relation to his job and duties.
- Perform other related duties as assigned to meet departmental and Company objectives.
Job Requirements
Job Requirements
- Pharmacist or Chemist.
- Languages: Good command of English.
- Ideal experience: 3-5 years in a similar position.
- Proven experience in the pharmaceutical industry.