Deviation Management Specialist

About the role

As a Deviation Management Specialist at Bamboohr, you will play a crucial role in ensuring the integrity and compliance of our pharmaceutical processes. This position involves overseeing and managing deviations from established protocols, ensuring that any discrepancies are thoroughly investigated and resolved in alignment with regulatory standards. You will collaborate with various departments to implement corrective actions and preventive measures, thereby enhancing the overall quality of our operations. Your expertise will contribute to maintaining Bamboohr's commitment to delivering safe and effective healthcare solutions.

Key facts

What you'll do

• Lead the investigation process for deviations, ensuring thorough root cause analysis is conducted to identify underlying issues.
• Collaborate with cross-functional teams, including Quality Assurance, Production, and Regulatory Affairs, to develop and implement corrective and preventive actions (CAPA) in response to deviations.
• Maintain comprehensive documentation of all deviation reports, investigations, and resolutions to ensure compliance with industry regulations and internal policies.
• Monitor and analyze trends in deviations to identify potential areas for improvement in processes and systems.
• Conduct training sessions for staff on deviation management procedures, emphasizing the importance of compliance and quality assurance.
• Serve as a point of contact for regulatory agencies during audits and inspections related to deviation management.
• Participate in the development and review of standard operating procedures (SOPs) to ensure they align with best practices in deviation management.
• Support the implementation of continuous improvement initiatives aimed at reducing the frequency and impact of deviations in operations.
• Ensure timely reporting of deviations to relevant stakeholders, including senior management and regulatory bodies, as required.
• Utilize data analysis tools to track and report on deviation metrics, providing insights for strategic decision-making.
• Assist in the preparation of regulatory submissions and documentation related to deviations and their resolutions.
• Foster a culture of quality and compliance within the organization by promoting awareness and understanding of deviation management processes.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• A minimum of 3 years of experience in deviation management or quality assurance within the pharmaceutical or biotechnology industry.
• Strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements related to deviation management.
• Proven experience in conducting investigations and implementing CAPA in a pharmaceutical setting.
• Excellent analytical skills with the ability to interpret complex data and identify trends.
• Strong communication skills, both verbal and written, with the ability to effectively convey information to diverse audiences.
• Detail-oriented with a strong commitment to maintaining high standards of quality and compliance.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in using quality management systems and deviation tracking software.

Nice to have

• Advanced degree (Master's or PhD) in a relevant field.
• Experience with regulatory submissions and interactions with health authorities.
• Familiarity with Lean Six Sigma methodologies or other continuous improvement frameworks.
• Knowledge of risk management principles as they apply to pharmaceutical operations.
• Certification in quality management or a related field (e.g., ASQ Certified Quality Auditor).

Skills & tools

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) for documentation and reporting purposes.
• Experience with quality management systems (QMS) and electronic document management systems (EDMS).
• Familiarity with statistical analysis tools for data trend analysis.
• Strong project management skills to handle multiple tasks and priorities effectively.
• Ability to work with cross-functional teams and influence stakeholders at all levels.

Practical notes

• This position is based in Egypt, and candidates must be eligible to work in the country.
• The salary for this role is competitive and commensurate with experience.
• Visa sponsorship may be available for qualified candidates.
• Interested applicants can apply through the following link: https://acino.bamboohr.com/careers/912.

Join Bamboohr as a Deviation Management Specialist and contribute to our mission of providing high-quality healthcare solutions while ensuring compliance and excellence in our operations. Your expertise will be instrumental in driving continuous improvement and maintaining the highest standards of quality within our organization.