Technical Support Team: Cleaning Validation Coordinator FTC

Purpose:

A Pharmaceutical company is seeking a Cleaning Validation Coordinator who is responsible to conduct the following activities within the Technical Support Team such as Process Validation, Technical Transfer, New Product Introduction, Hold Time Studies and relevant Investigations

Key Job Outputs:

• Perform all cleaning validation related activities
• Ensure the implementation of the cleaning validation programme
• Manage and execute project plans and ensure timelines and departmental deliverables are met
• Compilation and/or review, and execution of delegated protocols, reports and plans
• Ensure execution of validation activities are completed as per approved protocols and project plans
• Collate, analyse and discuss data in respective reports, and make recommendations
• Control and submission of samples for analysis and providing required documentation
• Assist with investigations and report writing
• Collect data from multiple sources for investigations
• Screen and evaluate data and make recommendations
• Identify, where possible, root causes of issues and plan a course of action for further investigation and/or corrective actions
• Complete investigations within allocated timelines
• Compile, update and review SOP’s timeously according to current procedures
• Ensure all Quality Management Systems (QMS) such as deviations, change controls and CAPAs are raised when required, and closure thereof completed within due dates
• Assist with preventative/corrective actions with regards to audit responses
• Ensure all work performed is of the highest quality and in full compliance with GxP’s, SOP’s, regulations and safety standards
• Administrative duties (filing and maintaining relevant data bases
• Recommendations made for Cleaning of equipment improvement and efficiencies
• Identify opportunities for process improvement and manufacturing cleaning release efficiencies
• Ensure all documentation is accurate and complete
• Completion of validation and verification process
• Control and submission of samples for analysis and providing required documentation
• Ensure procedures are implemented appropriately
• Ensure documentation is completed and accurate first time within agreed timelines
• Ensure inter and intra-departmental working relationships are maintained through good communication and liaisons

Core Competencies:

• Excellent computer literacy especially in MS Office mandatory
• Understanding of GLP, GMP, Regulatory guidelines (SAHPRA, ICH, etc.)

Qualifications:

• Matric Certificate
• Appropriate tertiary qualification and relevant experience

Experience:

• 3 – 5 years’ experience in a pharmaceutical manufacturing environment (specifically in production) or Direct experience is process validation
• Pharmacist Assistant Basic / Post-Basic advantageous but not necessary

Salary: Market related

Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful.

All personal information received will be processed in accordance with The Protection of Personal Information Act No. 4 OF 2013