Quality Senior Manager

The Quality Senior Manager vacancy at Chanelle Pharma Laboratories covers quality assurance and control for the company’s Jordan site in Amman. It is a full-time, senior-level post whose duties include laboratory oversight under cGMP, GLP and data integrity requirements.

About the quality senior manager job in Amman

Quality systems, regulatory compliance and continuous improvement initiatives all fall under the manager, who leads the quality assurance and control functions at the Jordan site. On the reporting side, the line is functional to the Head of Global Quality and Regulatory at Chanelle Group and administrative to the General Manager of the Jordan site.

Responsibilities

• Plans and coordinates Quality Control laboratory activities, among them analytical testing, sampling and stability work, against approved procedures, GLP, cGMP, data integrity principles and regulatory requirements
• Oversees laboratory operations, records, computerized systems and results, and sets controls that protect data integrity across paper and electronic records
• Leads the investigation of laboratory incidents, deviations, out-of-specification and out-of-trend results and data integrity concerns, and sees root-cause analysis through to corrective and preventive actions
• Reviews and approves investigation reports, deviations, CAPAs and change controls, along with laboratory procedures, analytical methods, specifications and qualification and validation documents
• Assigns responsibilities, balances workloads and builds the team’s capability, while trimming laboratory operating costs without compromising product quality, patient safety or compliance
• Defines and tracks performance, quality, compliance, capacity and cost indicators, and acts on the risks and improvement opportunities they show
• Trains and coaches laboratory staff on GLP, cGMP, data integrity, analytical procedures and investigations
• Keeps the laboratory ready for internal, corporate, customer and regulatory inspections, follows corrective actions through to completion, and works with Quality Assurance, Manufacturing, Regulatory Affairs, Supply Chain and Technical Services on quality issues

Requirements

• Bachelor’s degree in chemistry, chemical engineering, biology or pharmaceutical science
• Experience in complaint investigation, sample evaluation and report generation
• Broad knowledge of cGMP regulations and guidelines, with the ability to interpret and apply them
• Knowledge of conducting and leading internal and external GMP audits
• Data analysis skills to spot trends and key issues, and sound judgment in setting decision criteria and choosing a course of action
• Written and verbal communication with a broad group of personnel
• Computer skills, as the work involves computerized systems
• Handling multiple tasks while meeting agreed completion dates

Preferred qualifications

• Strong hands-on experience in analytical method development and validation

How to apply

Applications are submitted online through the company’s job page: apply using the button below.