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Regulatory Auditor
2 months ago
We are seeking a highly skilled GMP Quality Assurance Auditor to join our team at HAR Labcorp Early Development Laboratories Limited. As a key member of our quality assurance team, you will play a critical role in ensuring the site remains in a state of GMP compliance.
Key Responsibilities- Participate in quality issue resolutions and quality/effectiveness improvement initiatives to assess impact, investigate root cause, and plan and execute proposed actions.
- Monitor, compile, and report on quality metrics and data trends related to the local performance of the quality management system for input into the Management Review Process.
- Participate in the delivery of basic regulatory-based training.
- Support the internal audit program by participating in audits of systems, processes, and facilities.
- Study Specific Oversight: Provide regulatory review of study-related documentation prior to approval by senior GMP QA personnel.
- Support validation and verification activities, including protocol development and execution, deviation/non-conformance resolution, and review of key validation deliverables.
- Review metrology methods and specifications for accuracy/relevance and compliance with quality standards.
- Maintain processes to support document and configuration control requirements.
- Review and approve site-based controlled documents to ensure compliance with applicable regulations, document management procedures, and quality standards.
- Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities are followed.
- A competitive salary and benefits package, including health cover and contributory pension.
- Considerable interaction with internal and external stakeholders, including clients and regulatory bodies.
- Opportunity to develop and grow your career while making a difference in people's everyday lives.
- A culture of CARE with access to well-being programs and employee resource groups.
- Flexible and hybrid work arrangements once training is completed.
- An excellent relocation package (subject to criteria).
- A minimum of a Bachelor's Degree in a Chemistry or Biology-related discipline.
- Postgraduate degree (MSc or equivalent) in science or management-related discipline, preferable.
- Demonstrable experience of GMP auditing/laboratory work in a drug development/pharmaceutical setting.
- In-depth knowledge of Good Manufacturing Practice Regulations.
- General awareness of industry quality systems/standards, e.g., ICHQ10.
- Good communication, decision-making, negotiating, and problem-solving skills.
- Experience in process improvement.
- Customer service-oriented, i.e., ability to interact effectively with clients.
- Ability to work under minimal supervision.
- Strong verbal and written communication skills.
