Quality Control Specialist
Job description
About the role
As a , you will play a pivotal role in ensuring that our pharmaceutical products meet the highest standards of quality and safety. You will be responsible for conducting thorough inspections and tests on raw materials, in-process products, and finished goods to ensure compliance with regulatory requirements and internal quality standards. This position is essential for maintaining the integrity of our products and upholding Acino's commitment to excellence in the pharmaceutical industry.
Key facts
What you'll do
- Conduct routine inspections of raw materials, in-process products, and finished goods to ensure compliance with established quality standards.
- Perform analytical testing using various laboratory techniques and equipment to assess product quality and stability.
- Collaborate with production teams to identify and resolve quality-related issues, ensuring that corrective actions are implemented effectively.
- Maintain accurate and detailed records of quality control activities, including test results, deviations, and corrective actions taken.
- Participate in internal audits and inspections, providing necessary documentation and support to demonstrate compliance with regulatory requirements.
- Assist in the development and validation of new testing methods to enhance the quality control processes.
- Monitor and analyze quality trends, providing recommendations for continuous improvement initiatives within the quality control department.
- Train and mentor junior quality control staff on best practices and standard operating procedures to ensure a high level of competency within the team.
- Ensure that laboratory equipment is properly calibrated and maintained, adhering to safety and operational protocols.
- Collaborate with cross-functional teams, including regulatory affairs and production, to support product launches and ensure compliance with local and international regulations.
- Stay updated on industry trends and regulatory changes that may impact quality control practices, adapting processes as necessary.
- Contribute to the preparation of quality reports and presentations for management review, highlighting key findings and areas for improvement.
Requirements
- Bachelor's degree in a relevant field such as Chemistry, Biology, or Pharmaceutical Sciences.
- A minimum of 3 years of experience in quality control within the pharmaceutical or biotechnology industry.
- Strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements related to quality control.
- Proficiency in using laboratory equipment and analytical techniques, such as HPLC, GC, and spectrophotometry.
- Excellent attention to detail and strong analytical skills, with the ability to interpret complex data and make informed decisions.
- Effective communication skills, both written and verbal, to convey quality-related information clearly and concisely.
- Ability to work independently as well as collaboratively within a team environment, demonstrating strong interpersonal skills.
Nice to have
- Experience with quality management systems (QMS) and familiarity with ISO standards.
- Knowledge of statistical process control (SPC) and quality improvement methodologies such as Six Sigma or Lean.
- Previous experience in a regulatory role or with regulatory submissions is a plus.
Skills & tools
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) for documentation and reporting.
- Familiarity with laboratory information management systems (LIMS) and electronic quality management systems (eQMS).
- Strong problem-solving skills and the ability to think critically in high-pressure situations.
Practical notes
- This position is based in Egypt and may require occasional travel to other Acino facilities or regulatory agencies.
- The salary for this role will be competitive and commensurate with experience, reflecting the importance of quality control in our operations.
- Acino is committed to providing a supportive work environment that fosters professional growth and development, offering opportunities for further training and career advancement.
- Visa sponsorship may be available for qualified candidates who meet the requirements for employment in Egypt.
Join Acino and be part of a dedicated team that is committed to delivering high-quality pharmaceutical products that improve the lives of patients worldwide. If you are passionate about quality and have the skills and experience we are looking for, we encourage you to apply for the Quality Control Specialist position today!