Coordinator, Quality Validation & Eng RH

Performance Qualification, Sterilization Validation and Cleaning Validation.

• Quality Validation and Engineering RH Coordinators are expected to perform duties in one or more of several areas, including, Equipment Performance Qualification, Sterilization Validation, Cleaning Validation and the preparation of Validation packages (SPV) for regulatory submissions. Applicable duties from below shall apply.
• Author, co-ordinate execution and summarize Performance Qualification protocols for all applicable production equipment.
• Author, co-ordinate execution and summarize Sterilization Validation protocols for all applicable production equipment and all process simulations (media fills).
• Author and summarize all cleaning validation risk assessment reports.
• Author, co-ordinate execution and summarize cleaning validation protocols in accordance with FDA, HPFBI, EC, and ICH’s guidelines.
• Assess impact of proposed changes to validated production equipment / production processes and cleaning procedures
• Preparation of Sterilization Process Validation and other reports for regulatory submissions, including, responses to deficiencies, comparability protocols, new submissions and supplements.
• Operate and maintain equipment/instruments designated to Quality Validation & Engineering RH.
• Assist in calibration and calibrate equipment/instruments as required.
• Write SOPs or Change Control Forms in the area of expertise.
• Evaluate and execute requalification and revalidation when there is significant change in either product or its manufacturing process and for ongoing validation maintenance.
• Communicate with suppliers to obtain required technical information.
• Provide technical support in the area of expertise as required by other departments.
• Peer review of validation documentation for errors/omissions, comprehension and compliance with cGMP and SOPs.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

• Education
  • A Bachelor of Science degree in a related field or an engineering degree.
• Knowledge, Skills and Abilities
  • Proficiency in Written and Verbal English communication.
  • Knowledge of Excel, Word, other Microsoft office programs, and validation software packages would be an asset.
• Experience
  • Minimum of three to five years in Validation, with experience in sterilization validation, cleaning validation, equipment qualification and regulatory submission (sterilization).