Posted on :
2 Sep, 2013
2 Sep, 2013
Reporting to: Validation Coordinator
Ensure that all required documentation for all validation is compiled and approved to meet regulatory requirements. Effective. Responsible liaising with different departments to ensure all input is compliant and submitted timeously. Implementation, maintenance and periodic reviews of the Quality Management System including self-inspections. Assist with projects on an on-going basis.
• BSc Chemistry, ND Analytical Chemistry or equivalent
• Minimum of 6 years pharmaceutical experience or R&D environment.
• In depth knowledge of Quality Assurance, relevant Medicine Regulatory Authority Guidelines
• Thorough knowledge of MCC and all relevant ICH Guidelines and Pharmacopoeias
• Experience in the manufacture of various dosage forms e.g tablets, capsules, syrups and steriles
• Good knowledge/experience of analytical and formulation equipment processes. and qualification procedures
• Experience in validations and advantage
• Preparation of documentation of new and reformulated products in accordance with in-house and regulatory requirements.
• Preparation of documentation of new and existing equipment, instrumentation and utilities in accordance with in-house and regulatory requirements and maintenance of the calibration schedule.
• Perform validation of equipment/ manufacturing processes including reports.
• Evaluation of formulation and analytical reports.
• Ensure all auditing of documentation is co-ordinated to meet deadlines.
• Development, maintenance and continual improvement of the QMS.
• Compliance of procedures and facility with Total Quality Management, Good Manufacturing and Good Documentation Practices.
• Handle ad-hoc requests for data and other related tasks.
• Ability to work as part of a team and on own initiative
• Excellent decision making and problem solving skills
• Excellent planning and organising skills
• Excellent verbal and written skills
• Strong analytical and problem solving ability
• Excellent inter-personal and communication skills
• Good time management skills
• Excellent leadership skills
• Proficient computer skills (MS Office, MS Excel)
How to Apply
Saturday, 14 September 2013