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Senior Quality Control Analytical Consultant
2 months ago
Senior Quality Control Analytical Consultant
KEY RESPONSIBILITIES
- Effectively managing a team of analysts to conduct essential testing of products, raw materials, and environmental conditions for biopharmaceutical facilities and contract laboratories.
- Ensuring adherence to quality control testing protocols in line with ICH and GMP standards, as well as industry best practices.
- Supervising the formulation and execution of sampling strategies for both internal facilities and contract partners.
- Creating comprehensive sampling strategies to enhance manufacturing processes while ensuring optimal testing efficiency.
- Overseeing the drafting, assessment, and modification of quality control testing specifications.
- Guaranteeing that both internal and external specifications align with health authority regulations.
- Establishing and maintaining a robust equipment maintenance program to facilitate necessary preventative maintenance and calibration.
- Ensuring that all quality control testing instruments are calibrated and maintained in accordance with regulatory standards.
- Maintaining data integrity within Quality Control through proper generation and storage practices.
- Evaluating equipment and processes to ensure compliance with data integrity standards.
- Providing expert insights on data integrity to various departments within the organization.
- Building and nurturing strong relationships with key stakeholders, both within and outside the organization.
- Balancing the operational demands of internal facilities with those of contract suppliers.
- Guiding and mentoring emerging leaders by sharing knowledge and best practices.
- Proactively identifying and addressing conflicts as they arise.
- Developing partnerships with external entities to remain informed about industry advancements.
- Promoting a culture that values innovative thinking and encourages advancements in quality control methodologies.
- Tackling systemic challenges within the organization with integrity and resolve.
- Making informed decisions with respect, empathy, and integrity, while taking calculated risks when necessary.
- Exhibiting credibility at the organizational level through strategic leadership and decision-making.
- Taking responsibility for actions and decisions while achieving results aligned with quality objectives.
- Creating opportunities for knowledge sharing and collaboration across various departments.
- Leading organizational change initiatives by articulating a clear vision and direction.
- Fostering a culture that embraces innovation and change in quality control practices.
QUALIFICATIONS
- At least 10 years of experience in quality control within the biopharmaceutical or biotechnology sectors.
- In-depth knowledge of regulatory standards pertaining to quality control testing.
- Exceptional leadership and interpersonal capabilities.
- Strong communication and problem-solving skills.
- Demonstrated success in driving innovation and change within quality control processes.
EDUCATION
- Bachelor's or advanced degree in a relevant discipline (e.g., Chemistry, Biochemistry, Pharmaceutical Sciences).
