QC Supervisor

About the Company

About the Position

Key Responsibilities

• Oversees the chemical analysis and quality issues of raw materials, packaging components, in-process, finished product and stability samples and ensures that testing results provide the highest quality support for manufacturing in compliance to cGMP, SOPs and quality standards.
• Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs) and escalates related issues to Site Director of Quality in a timely manner.
• Participate directly in and support all relevant regulatory and customer inspections including the provision and maintenance of adequate records, processes and documentation for inspection.
• Collaborates with the internal departments on a regular basis to gain oversight on the weekly manufacturing production / final release product planning and assists in the creation of the test schedule for the QC team.
• Supervision of lab personnel through the provision of clear objectives, positive employee environment, effective team working and adequate support to ensure their successful and effectively delivery of excellent customer service to all relevant stakeholders
• Develop and maintain quality systems within the laboratory to ensure ongoing compliance with cGLP.
• Development and updating of SOPs, validation protocols, validation reports and method validation / verifications and equipment qualifications.
• Ensure timely completion of laboratory investigation, deviations, change controls and environmental out of specification results.

Experience/Requirements

• Bachelor’s Degree within a Scientific Discipline essential
• Minimum 10 years’ experience in GMP environment within a pharmaceutical (HPLC) environment.
• Minimum 5 years’ experience in a leadership role.
• Strong analytical/quantitative skills
• Excellent technical writing skills
• Good understanding of root cause analysis and its application
• Good computer skills with high proficiency in Microsoft Office a plus
• Thorough understanding of quality systems and cGMPs.

Remuneration Package

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