Quality Assurance Lead

General Information

Malia Group
Job Type:
Health Care/ Pharmaceutical
Date Posted:
Sep 01, 2022
Employee Type:
Full-Time Employee


- Job Purpose:
1- Responsible for validating Quality Assurance Policies & Procedures and ensure their proper implementation through proper communication and training
2- Responsible for conducting and monitoring internal inspections and quality audits to ensure that site practices are aligned with set GMP guidelines

- Duties & Responsibilities:
1- Review and approve SOPs and Work instructions
2- Approve production batch files activities and review related analytical data for finished products release
3- Approve trend analysis reports prepared by the team; gather data and propose process modification when needed
4- Monitor, review and ensure implementation of Pharmacovigilance plan
5- Prepare, review and approve Quality Agreements for service providers, suppliers and licensors and collaborate with concerned for agreement finalization and ensure timely execution
6- Monitor and follow up on Risk Assessment, Impact Assessment and Worse Case studies for products, processes, equipment, methods and systems with concerned departments
7- Monitor and follow up on validation programs for production and cleaning processes with concerned departments
8- Investigate and follow up on deviations, out-of-specifications and complaints with concerned departments
9- Conduct and monitor internal audits and regular inspections to ensure GMP guidelines are respected. Share deviations, if any, with concerned department and follow up on corrective action
10- Ensure proper implementation of corrective or preventive actions after self-inspections and external audits
11- Participate in audits and define with the Quality Team the corrective action and preventive measures to be implemented. Follow up to ensure that corrective actions are implemented and audit report is closed
12- Report on yearly basis to the Head of QA all Self inspection and Internal Audits outcome and implemented improvement
13- Control reports prepared by the team on monthly basis on all non-conformities in each department and make sure all detailed reports are sent to related head of department for their action; ensure execution of corrective actions
14- Contribute with other departments in new projects to fulfill GMP guidelines
15- Contribute proactively with the Talent Acquisition Team in filling vacancies timely. Design/update related JD and on-boarding programs and ensure their proper understanding & implementation. Ensure an optimized structure in line with business priorities and performance
16- Provide direct reports with needed resources/tools and guidance to fulfil their role properly and set their training needs and development plan in coordination with L&DM. Celebrate achievements, highlight people with potential to offer them perspective for growth
17- Set direct reports annual Business Goals and required competencies and conduct quarterly feedback sessions to appraise their performance. Monitor continuously direct report productivity and take corrective actions in due time. Issue misconducts and enroll under-performers in related program
18- Promote the Group's culture, encourage loyalty, trust, a healthy working environment and teamwork. Personalize the motivational approach, empower and inspire the team to reach greatness

- Education:
Bachelor of Science in Pharmacy

- Experience:
Minimum 4 years of experience in QA field

Company Profile