Operations Lead
2 months ago
- Policy Enforcement & Compliance:
- Enforce company policies and standard operating procedures in collaboration with the QA Manager.
- Ensure data integrity and compliance with regulatory standards.
- Manage analytical laboratory operations in accordance with current Good Practice regulations (cGXP) and industry guidelines.
- Collaborate with the People, Culture, and Purpose Manager on discipline, leave, and performance management.
- Foster a culture of continuous improvement and high performance.
- Recruit, build, and inspire a competent and equitable team.
- Oversee projects and outsourced services, ensuring the qualification of service providers and suppliers.
- Manage sourcing from an approved suppliers list.
- Implement and maintain laboratory equipment, calibration schedules, and apparatus maintenance programs.
- Arrange for equipment servicing and repairs as needed.
- Ensure compliance with Health and Safety regulations in the workplace.
- Supervise waste management and laboratory access.
- Plan and execute projects in collaboration with the QA Lead and Technical Director.
- Train team members on new testing methods and ensure technical competency.
- Lead analytical research, including stability, method verification, and method validation.
- Bachelors degree in Chemistry (essential).
- Extensive knowledge of cGxP regulations and pharmaceutical regulatory requirements.
- Proficient in analytical techniques and statistical analysis.
- Excellent computer skills (MS Office, Chromeleon, LIMS).
- Minimum of 10 years in laboratory experience.
- At least 5 years in a Laboratory/Operations Lead role.
- Experience in technical document compilation, document control, and data integrity.
- Strong leadership and communication abilities.
- Deadline-driven, with a focus on quality and detail.
- Ability to work well under pressure and function as part of a team.
- Proactive and analytical mindset.
- Opportunity to lead a dynamic team in a state-of-the-art laboratory setting.
- Be at the forefront of ensuring quality and regulatory compliance in the industry.
If this role aligns with your career aspirations and skill set, we encourage you to apply.
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