Quality and Compliance Consultant

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).

Administration:

• 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.

Requirements

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.

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.