About Chanelle Pharma:
This is an opportunity to be part of a dynamic team within the Quality function. We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.
An important role in the QA department, reporting directly to the Head of Quality, the Validation Engineer will be responsible for reviewing and issuing of validation protocols and reports and also the co-ordination of the execution of validation activities (process / cleaning and equipment and computer qualifications) with the relevant departments within the Chanelle Group.
· Contribute on the preparation and review of the Validation Master Plan – Process and Cleaning
· Manage the validation requirements of Chanelle and third party suppliers and CMO’s
· Manage the preparation, review and issuing of Validation Protocols and Reports (this to include equipment, cleaning, process and computer system validation)
· To maintain and take responsibility for the cleaning validation strategy at Chanelle
· To assume responsibility for the cleaning validation master plan confirming to accepted practices and demands of the competent authorities in the EU
· Implementation of Process Validation of new products for regulatory submissions ensuring compliance to proposed registered specifications
· Coordination of the execution of Validation in accordance with protocols by Production, Quality Control and R&D teams
· Establishing, implementing and directing validation and revalidation activities
· Liaise with contract manufacture customers in seeking their approval for protocols and reports where appropriate
· Reviewing and managing Change Control Forms for Validation implications
· Reviewing and managing Non-Conformances for Validation Implications
· Updating existing quality documentation related to validation activities
· Identifying training requirements in support of validation
· Ensuring completion of validation protocols
· Carry out Internal Audits as required
· Responsible for the execution of Risk Assessments or Investigation reports relative to the role
· Maintaining validation documentation system
· Required to Lead cross functional teams providing knowledge in resolution in any technical issues
· Assisting in the preparation and hosting of associated regulatory and customer audits
· Good verbal and written communication skills and the ability to work independently in analytical; environment
· Good computer skills with Word, Excel and any other statistical programs
· Knowledge of Process and Cleaning Validation
· Ability to conduct internal audits
· Ability to perform in external audits
•Bachelor’s degree in Science, Engineering, Technology or a related discipline.
•Experience working within a Pharmaceutical Laboratory, Quality Assurance or Regulatory Environment.
• Good grasp of the Microsoft Office Suite, in particular Microsoft Excel
• Displays a working knowledge of relevant pharmaceutical regulations including GMP, GLP and ideally ICH.
PHYSICAL DEMANDS: Health & Safety requirements (e.g., Manual Handling Training)
- Manual Handling
WORK ENVIRONMENT: (e.g., Office, Production)
HOURS OF WORK
- 08:30 – 17:00 (Monday – Thursday)
- 08:30 – 16:00 (Friday)