QUALITY ASSURANCE (QA) Manager:
Etook Pharma Drugs Production
Published Date: • Herat, Afghanistan (On-Site)
Description
The selected candidate will be responsible for managing the overall quality assurance activities, including the development, implementation, and maintenance of quality management systems such as CAPA, deviation handling, change control, and validation processes. They will ensure accurate pharmaceutical documentation and data integrity throughout the manufacturing lifecycle. The role also involves preparing for and supporting regulatory audits and inspections, fostering a culture of continuous improvement, and leading compliance efforts in line with pharmaceutical industry best practices. Candidates with experience in manufacturing oral liquids, suspensions, topical preparations, and solid dose forms will be at an advantage. Proficient communication and documentation skills in English alongside strong computer competencies are essential to succeed in this role.
Responsibilities
- Develop, implement, and maintain effective Quality Management Systems to ensure compliance with WHO-GMP and other regulatory standards.
- Lead and manage the QA team of two, providing guidance, coordination, and support to achieve departmental objectives and maintain high-quality standards.
- Oversee risk management activities by identifying quality risks and implementing appropriate controls to mitigate potential issues.
- Manage deviation reports, change controls, CAPA processes, and validation protocols to maintain product quality and process consistency.
- Review and ensure the accuracy of pharmaceutical documentation, ensuring data integrity and compliance with documentation standards.
- Coordinate and support internal and external audits, including regulatory inspections, by preparing documentation, conducting trainings, and addressing findings effectively.
- Collaborate closely with production and other departments to resolve quality-related issues and improve manufacturing processes.
- Ensure continuous training and development of the QA team, fostering a culture of quality awareness and improvement.
- Monitor and evaluate quality performance metrics and KPIs to drive quality enhancement initiatives.
- Handle investigations related to out-of-specification (OOS) and out-of-trend (OOT) results, implementing corrective actions as necessary.
- Manage regulatory submissions related to quality assurance and maintain up-to-date knowledge of evolving regulatory requirements.
- Oversee quality compliance for products including oral liquids, suspensions, topical preparations, creams, ointments, gels, tablets, capsules, and vial ampoules when applicable.
- Maintain effective communication and documentation in English, ensuring timely and clear reporting of quality issues and outcomes.
- Utilize computer systems and software efficiently to document, track, and report quality assurance activities.
- Promote continuous improvement by staying current with industry trends, standards, and best practices relevant to pharmaceutical quality assurance.
Experience
7 Years
Apply By
Required Skills
- Quality Management Systems
- Risk Management
- Team Leadership and Coordination
- Good Manufacturing Practices (GMP)
- Corrective and Preventive Actions (CAPA)
- Deviation and change control management
- Validation protocols
- Pharmaceutical Documentation
- Data Integrity
- Regulatory Inspections and Audits
- Out Of Specification (OOS) and Out Of Trend (OOT) Management
- Pharmaceutical Quality Compliance
- Audit Preparation and Support
Nice to Have Skills
- Product Quality Control for Pharmaceutical Forms
- Computer skills
- Documentation Skills