Quality Control Senior Specialist

About the role

As a , you will play a pivotal role in ensuring that our pharmaceutical products meet the highest standards of quality and compliance. You will be responsible for overseeing quality control processes, conducting thorough inspections, and implementing quality assurance protocols. This position is essential in maintaining our commitment to delivering safe and effective medications to our customers. Your expertise will contribute significantly to our mission of enhancing patient health and well-being.

Key facts

What you'll do

• Lead and manage quality control activities to ensure compliance with regulatory requirements and internal standards.
• Develop and implement testing protocols and methodologies for raw materials, in-process products, and finished goods.
• Conduct routine inspections and audits of production processes to identify areas for improvement and ensure adherence to quality standards.
• Collaborate with cross-functional teams, including production, research and development, and regulatory affairs, to address quality-related issues.
• Analyze and interpret data from quality control tests, preparing detailed reports to communicate findings and recommendations to management.
• Train and mentor junior quality control staff, fostering a culture of quality awareness and continuous improvement within the team.
• Participate in the development and revision of standard operating procedures (SOPs) to enhance operational efficiency and compliance.
• Manage deviations and non-conformances, ensuring timely investigation and implementation of corrective actions.
• Stay updated on industry trends and regulatory changes to ensure that quality control practices remain current and effective.
• Support the preparation for regulatory inspections and audits, providing necessary documentation and evidence of compliance.
• Conduct stability studies and evaluate the shelf life of products to ensure they meet quality specifications throughout their intended lifespan.
• Collaborate with suppliers to ensure the quality of raw materials and components used in production processes.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related field.
• A minimum of 5 years of experience in quality control within the pharmaceutical or biotechnology industry.
• Strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements (e.g., FDA, EMA).
• Proven experience in conducting quality audits and inspections.
• Proficiency in analytical techniques and laboratory equipment used in quality testing.
• Excellent problem-solving skills and attention to detail, with the ability to analyze complex data sets.
• Strong communication skills, both written and verbal, with the ability to convey technical information clearly to diverse audiences.
• Ability to work effectively in a team-oriented environment and manage multiple priorities simultaneously.
• Familiarity with quality management systems (QMS) and software applications used in quality control processes.

Nice to have

• Certification in Quality Control or Quality Assurance (e.g., ASQ Certified Quality Auditor).
• Experience with stability testing and evaluation of pharmaceutical products.
• Knowledge of risk management principles and methodologies in quality assurance.
• Familiarity with electronic laboratory notebooks (ELN) and data management systems.
• Experience in leading quality improvement initiatives or projects.

Skills & tools

• Proficient in using laboratory equipment such as HPLC, GC, UV-Vis spectrophotometers, and other analytical instruments.
• Strong analytical skills with experience in statistical analysis and quality control tools (e.g., Six Sigma, SPC).
• Familiarity with document management systems and quality management software.
• Proficient in Microsoft Office Suite (Excel, Word, PowerPoint) for data analysis and report preparation.

Practical notes

• This position is based in Egypt, and candidates must be eligible to work in the country.
• The salary for this role will be competitive and commensurate with experience.
• Acino is an equal opportunity employer and encourages applications from diverse backgrounds.
• Interested candidates can apply through the official link: https://acino.bamboohr.com/careers/803.

At Acino, we are dedicated to fostering a culture of excellence and innovation. As a Quality Control Senior Specialist, you will have the opportunity to make a significant impact on our operations and contribute to the health and well-being of patients worldwide. If you are passionate about quality and compliance in the pharmaceutical industry, we invite you to join our team.