Validation Lead
Posted 2 days ago by Sterling Engineering Limited
Validation Lead
Role Overview:
- A fantastic company who are committed to maintaining the highest standards of pharmaceutical validation to ensure the safety and efficacy of our products.
- As a Validation Lead, you will play a crucial role in overseeing validation activities across our operations, collaborating with various departments to uphold regulatory compliance and quality standards.
Responsibilities include:
- Contribute to the preparation and review of the Validation Master Plan for process and cleaning validation.
- Manage validation requirements for the Company and third-party suppliers and Contract Manufacturing Organizations (CMOs).
- Oversee the preparation, review, and issuance of validation protocols and reports, encompassing equipment, cleaning, process, and computer system validation.
- Maintain and take ownership of the cleaning validation strategy at Chanelle, ensuring compliance with regulatory authorities in the EU.
- Establish, implement, and direct validation and revalidation activities.
- Liaise with contract manufacturing customers to obtain approval for protocols and reports when necessary.
Competencies:
- In-depth knowledge of process and cleaning validation.
- Ability to conduct internal and external audits effectively.
- Minimum Bachelor of Science or Engineering degree.
- Health & Safety requirements, including Manual Handling Training.
- Ability to ensure compliance with safety regulations and maintain a safe work environment.
- Familiarity with HPRA and USFDA regulations and experience in regulatory compliance.
- Minimum of 2 years of relevant experience in a similar position.
- Type:
- Permanent
- Start Date:
- Immediate
- Contract Length:
- Ongoing
- Contact Name:
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- Telephone:
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- Job Reference:
- KNYL 1487
- Job ID:
- 221740306
- Applications:
- Less than 10
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