Regional Quality and Regulatory Affairs Manager
Pharmamed
Total des années d'expérience :10 years, 7 Mois
Responsible for the implementation of the Quality Management System (including procedures, processes, internal audits, risk assessment, management review...), the Good Storage and Distribution Practices, the local Code of Ethics, FCPA and UK bribery Act.
Responsible for the management of the regulatory affairs department including follow-up on new projects assessment, new files submission, notification and variation submission, pricing and re-pricing
Handle company and all products registration activities in the MENA region (e.g.: UAE, KSA, Iraq, Tunisia, Kuwait…).
- Ensure compliance to all requirements in target countries.
- Screen regulatory requirements for products and company registration in the target countries.
- Interface between local distributors and manufacturing site/ marketing authorization holder for documents preparation and compliance.
- Make sure all the needed documents and all requirements are fulfilled before dossier submission.
- Follow-up on products and company registration.
- Establishment of efficient quality system.
1- Handling of production and packaging operations through production and packaging personnel in charge
2- Initiation and reviewal of production and packaging documents (Standard operating procedures, Production master formula and Master packaging instructions)
3- Reviewal of production and packaging batch records
4- Insurance of compliance to cGMP in all production and packaging activities
5- Training of staff on internal procedures, and on cGMP requirements especially “Manufacture of sterile medicinal products”
6- Supervision of media fill process including media fill scheduling
7- Follow-up on production equipment calibration and validation
8- Insurance of adherence to aseptic manipulations
9- Insurance of adherence to decontamination/ disinfection program rotation
1- cGMP training
2- Assurance of cGMP compliance
3- Initiation, reviewal and approval of documents (Standard operating procedures, Production master formula …)
4- Handling of deviations and non-conforming product
5- Performance of customer satisfaction survey
1- cGMP compliance
2- Initiation of production and packaging batch records:
a- MFM (Master Formula & Method)
b- MPI (Master Packaging Instructions)
c- MFP (Media Fill Protocol)
3- Initiation of production, packaging and warehouse SOPs (Standard Operating Procedures)
4- Packaging process management
5- Warehousing, inventory and stock control
6- Product development (Initiation of technical specifications…)
1- Patients advisory and drug information
2- Prescriptions delivery
3- Stock control