Offered Salary 21000
Career Level Manager
Experience 8 Years +
Industry Health care
Qualifications Master’s Degree
Quality Management (QM):
• Leads the project’s development and/or review of procedures, SOP’s and other documents related to the Quality systems.
• Maintains Good Documentation practice (GDP) in a quality system for new projects.
• Ensures project compliance with all relevant GMP and Quality requirements.
• Manages the implementation of Quality system elements pertaining to Change Control, Risk Mitigation, and validation status as stated in the Statement of Work (SOW).
• Ensures all project documentation follows company and regulatory requirements.
• Completes all required reports and administrative tasks within designated timeframes.
Knowledge and Compliance:
• Maintains current knowledge of topics relevant to the role, the business, and International standards through attendance at seminars, lectures, meetings, and professional conferences.
• Maintains knowledge of technological advancements in areas relevant to the role.
• Maintains up-to-date knowledge of industry trends, cutting-edge practices, and techniques relevant to role and business.
• Ensures all Company related activities comply with relevant Acts, legal demands, and ethical standards at all times.
Extensive knowledge in Quality and Regulatory tools:
• Risk management (ICH Q9), Pharmaceutical Quality System (ICH Q10), Post-Marketing Changes (ICH Q12).
• Quality Management System tools (PDCA Cycle, FMEA)
• Root Cause analysis and/or Problem-solving approaches.
• Proficient in statistical analysis.
• Project Management Planning.
• Excellent understanding of GxP principles: Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP); and Project Management principles.
Key Authorities (Decision Making):
• Must be able to work with little or no supervision.
• Work will often be performed within a cross-functional framework. A high degree of original thinking, resourcefulness, and networking will be required to coordinate projects or solve problems.
Relevant Qualifications: –
- Bachelor’s degree in Science preferably in Pharmacy/Chemistry/Microbiology and Biochemistry
- Minimum of 5 years’ management experience and 5 years in Quality Assurance, Validation or Quality Control roles in the Pharmaceutical/Biotech/Medical device or Life Sciences industry.
- Advanced degrees may compensate for the required experience stated above.
- With sufficient knowledge of spoken and written English.