An important role in the QA department, reporting directly to the Head of Quality, the Validation Engineer will be responsible for reviewing and issuing 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.
KEY RESPONSIBILITIES:
1. Contribute on the preparation and review of the Validation Master Plan – Process and Cleaning
2. Manage the validation requirements of Chanelle and third party suppliers and CMO’s
3. Manage the preparation, review and issuing of Validation Protocols and Reports (this to include equipment, cleaning, process and computer system validation)
4. Maintain and take responsibility for the cleaning validation strategy at Chanelle
5. Assume responsibility for the cleaning validation master plan confirming to accepted practices and demands of the competent authorities in the EU
6. Implementation of Process Validation of new products for regulatory submissions ensuring compliance to proposed registered specifications
7. Coordination of the execution of Validation in accordance with protocols by Production, Quality Control and R&D teams
8. Establishing, implementing and directing validation and revalidation activities
9. Liaise with contract manufacture customers in seeking their approval for protocols and reports where appropriate
10. Reviewing and managing Change Control Forms for Validation implications
11. Reviewing and managing Non-Conformances for Validation Implications
12. Updating existing quality documentation related to validation activities
13. Identifying training requirements in support of validation
14. Ensuring completion of validation protocols
15. Carry out Internal Audits as required
16. Responsible for the execution of Risk Assessments or Investigation reports relative to the role
17. Maintaining validation documentation system
18. Lead cross functional teams providing knowledge in resolution in any technical issues
19. Assist in the preparation and hosting of associated regulatory and customer audits
COMPETENCIES:
* 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
QUALIFICATIONS:
Minimum Bachelor of Science or Engineering
PHYSICAL DEMANDS: Health & Safety requirements (e.g., Manual Handling Training)
1. Take reasonable care for their own safety, health and welfare at work and that if any other person that may be affected by their actions or omissions while at work
2. Cooperate with Chanelle or any of its representatives that will enable the company to comply with the relevant health and safety statutory provisions
3. Adhere to safety regulations by ensuring correct usage of PPE in laboratory and production areas
4. Report to the supervisor or health and safety representative without unreasonable delay of any defects in plant, equipment, place of work, system or work which might endanger safety, health or welfare of themselves or any employee, contractor or visitor to the company
5. Keep work area safe, clean and tidy
REQUIRED TRAINING:
* Manual Handling Training
* Working on PC
PERSON SPECIFICATION:
B.Sc. / M.Sc. in Scientific Discipline
HPRA / USFDA Experience
Minimum 2 years relative experience in a similar position
Demonstrated ability to work and communicate effectively cross-functionally with all levels of management
Proactive, motivated, analytical and strategic thinker.
Chanelle Pharma
Dublin Road, Loughrea,
Co Galway, Ireland.
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