Validations Coordinator - Process

SUMMARY:
-

POSITION INFO:

• Decide on a Validation Strategy based on the information supplied from the Technical Transfer team
• Perform Risk Assessments to determine the extent and the scope of the protocol.
• Plan and execute process validation protocols to ensure consistency and reproducibility of manufacturing processes
• Establish Critical Process Parameters, determine the suitability of the equipment used in each step and ensure alignment of any Automated Systems to the Batch Manufacturing Records
• Where concurrent Process Validation has been approved, write up interim reports for each of the batches and a Final Summary report when the number of batches for process validation is determined by the Risk Assessment.
• If any deviation is observed, ensure that deviations are raised by the respective department.
• Where recommendations have been approved, raise a change control through the QMS system to ensure changes are implemented
• Ensure a robust and reliable process validation to ensure compliance with the Clayville Manufacturing Quality Management Systems (QMS) & cGMP regulatory requirements
• Partake in compliance inspections and inquiries from Regulatory Agencies
• Ensure process validations are performed as per schedule
• Identify training requirements in support of process validation
• Analyse and interpret statistical information of the Critical Quality Attributes to prove consistency and reproducibly of process
• Update Standard Operating Procedures for Process Validation when necessary
• Administer troubleshooting efforts for protocol discrepancies
• Ensure compliance to all local site company policies, procedures, and corporate policies
• Ensure the use of current SOP’s and guidelines
• Explore process improvement opportunities
• Serve as the technical expert for various Manufacturing processes
• Implement regulatory and cGMP requirements where necessary
• Initiate & drive continuous improvement programs
• Remain up to date on cGMP and Regulatory requirements for process validation

Minimum requirements

• Diploma in Chemical Engineering, Analytical Chemistry, Biochemistry / Biotechnology, or relevant qualification
• A minimum of 5 years’ experience in the Validation and pharmaceutical industry
• A good understanding of the manufacture of Tablets, (dry and wet granulation), syrups, and suspensions
• A good understanding of the sterile manufacturing concept and associated processes such as the media fill, media hold, dirty and clean hold time studies.
• A good understanding of the cleaning validation concept including CIP and COP systems.
• Good working knowledge of Process Validation
• Proficient in the use of structured problem-solving tools such as Process Mapping, RCA (Root cause analysis), FMEA''s (Failure Mode effects analysis), etc
• Proficiency in Microsoft Office including Word, Excel, PowerPoint & Project Management