LOCATION – Town / City Ilupeju-Lagos
LOCATION – Country Nigeria
REPORTING TO (JOB TITLE): Head of Regulatory (Rx)
TYPE OF POSITION: Permanent
JOB ADVERT JOB PURPOSE/SCOPE
Responsible for ensuring that Pharma products are manufactured at third parties and GSK facilities to meet local regulatory standards and GSK Quality Management System requirements
KEY RESPONSIBILITIES
Ensure that only wholesome products are manufactured and released to the market
Manages processes to achieve Right First Time Quality Products and reduced process wastage
Ensure Quality process documentation and compliance to maintain consistency in batch to batch and in line with regulatory requirements
Manages Product complaints and returned goods handling and investigation to identify weakness in processes, materials, equipment and methods with a view to eliminating them and improving customer satisfaction
Manages Change Control processes at 3rd parties maintain Periodic Product Review of Pharma products, so as to ensure that all changes that will impact quality are well considered and appropriate approval sought before changes are implemented
Manages 3rd party inspection and quality audit processes to assure that Production and Quality processes are in place, effective and complied with at all times ; manage and review CAPAs from L2 audits
Manages technical transfer and analytical transfer of Pharma products.
Generates and reviews batch documents and SOPs.
Collaborates with Purchasing, Logistics and Pharma Commercial for production planning and production execution
Provides all necessary information required on-time registration of existing and new products by NAFDAC and other relevant regulatory bodies.
Provides relevant technical information to Copied from Regulatory department and other departments in Commercial.
Support Supplier development programme so as to ensure the quality of all inputs into the production process.
QMS champion for the Pharma Business Unit overseeing all QMS related activities for the AWA markets reporting to the QMS Co-coordinator, Head of Regulatory Affairs, AWA
QUALIFICATIONS, EXPERIENCE
Bachelor of Pharmacy degree
Not less than 5 years hands –on experience in the Pharmaceutical production and Quality Assurance operations.
Additional educational qualification in Pharmaceutics at post graduate level and exposure to Quality Management systems application to Pharmaceutical
Quality Assurance is desirable
Good Communication skills
Fair knowledge of Engineering and process operations
Computer literacy
COMPETENCIES
Sound knowledge of manufacturing processes
In-depth experience and application of Quality Management System
High level of creativity, assertiveness and bias for problem solving
Effective leadership skills.
Computer literacy and good statistical data management
CLICK HERE TO APPLY
DUE DATE: 03/08/12.
