QA Sr. Specialist (Sterile Area)

About the role

As a QA Senior Specialist in the Sterile Area at Acino, you will play a pivotal role in ensuring the highest quality standards in the production of sterile pharmaceutical products. Your expertise will contribute to maintaining compliance with regulatory requirements and internal quality standards, ultimately ensuring patient safety and product efficacy. This position is based in Cairo, Cairo, and offers an exciting opportunity to work in a dynamic environment where your skills in quality assurance will be highly valued.

Key facts

What you'll do

• Oversee and manage quality assurance processes within the sterile manufacturing area, ensuring adherence to Good Manufacturing Practices (GMP) and other regulatory requirements.
• Conduct routine inspections and audits of sterile production processes to identify areas for improvement and ensure compliance with established protocols.
• Collaborate with cross-functional teams, including production, engineering, and regulatory affairs, to resolve quality issues and implement corrective actions.
• Develop and maintain quality documentation, including standard operating procedures (SOPs), batch records, and validation protocols, ensuring they are up-to-date and compliant with regulatory standards.
• Lead investigations into quality incidents, deviations, and non-conformances, performing root cause analysis and implementing effective corrective and preventive actions.
• Provide training and guidance to staff on quality assurance practices, sterile techniques, and regulatory requirements to foster a culture of quality within the organization.
• Monitor and analyze quality metrics and trends, preparing reports for management to facilitate informed decision-making regarding quality improvements.
• Participate in regulatory inspections and audits, serving as a key point of contact for quality-related inquiries and demonstrating the company's commitment to quality assurance.
• Stay current with industry trends, regulatory changes, and advancements in quality assurance methodologies, applying this knowledge to enhance the quality systems at Acino.
• Support the validation of new equipment and processes within the sterile area, ensuring that all systems are compliant and capable of producing high-quality products.
• Assist in the development and execution of quality improvement projects aimed at enhancing product quality and operational efficiency.
• Foster strong relationships with external stakeholders, including suppliers and regulatory agencies, to ensure alignment on quality expectations and requirements.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related field; a Master's degree or relevant certifications in quality assurance is a plus.
• A minimum of 5 years of experience in quality assurance within the pharmaceutical or biotechnology industry, specifically in sterile manufacturing environments.
• In-depth knowledge of GMP regulations, quality systems, and regulatory compliance requirements applicable to sterile products.
• Proven experience in conducting audits, inspections, and investigations, with a strong understanding of root cause analysis techniques.
• Excellent communication skills, both written and verbal, with the ability to effectively convey complex information to diverse audiences.
• Strong analytical and problem-solving skills, with a keen attention to detail and a commitment to maintaining high-quality standards.
• Ability to work collaboratively in a team-oriented environment while also demonstrating independence and initiative in managing quality-related tasks.

Nice to have

• Experience with quality management systems (QMS) and electronic documentation systems.
• Familiarity with risk management principles and methodologies in a pharmaceutical context.
• Previous experience in leading quality improvement initiatives or projects.
• Knowledge of international regulatory requirements, including those from the FDA, EMA, or other health authorities.
• Proficiency in additional languages is an advantage, particularly Arabic or English.

Skills & tools

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and quality management software.
• Strong understanding of statistical analysis tools and methodologies for quality data analysis.
• Familiarity with laboratory equipment and sterile manufacturing processes.

Practical notes

• This position is based in Cairo, Cairo, and may require occasional travel for audits and inspections.
• Candidates must be eligible to work in Egypt and may require assistance with visa sponsorship, depending on their nationality.
• The company offers a competitive salary and benefits package, commensurate with experience and qualifications.

META

Company: Acino

Title: QA Sr. Specialist (Sterile Area)

Listed

location: Cairo, Cairo

Job type: Active