Quality Compliance Manager at Sygen Pharmaceuticals Limited

Key Responsibilities 

•  Define adequate operating procedures and controls for all plant processes in order to assure that all products that have been manufactured meet both internal and external specifications, with the goal of maximizing customer satisfaction and legal compliance.
• Review and monitor adherence to Sygen’s company policies, regulations, defined Quality Standards and Standard Operating Procedures to ensure effectiveness.
• Ensure all production procedures and work instructions are documented, controlled and communicated effectively through training of relevant staff members.
• Delivering employee training on compliance issues where applicable.
• Manage Change Control process to ensure that all changes that may impact product quality are communicated and appropriate approval sought before changes are implemented.
• Manage the Deviation Handling, develop reports and ensure Corrective actions and Prevention actions (CAPA) are generated with appropriate closure.
• Manage the Self Inspection processes, so as to assure that Production and Quality systems are compliant and robust enough to meet GMP requirements at all times.
• Assures audit reports and observations are consistent with procedural requirements (WHO CGMP/NAFDAC Inspection Guidelines) and immediately notifies Head Quality of potentially critical observations
• Liaise with the Procurement Manager to establish and maintain external Supplier Quality standards, develop and maintain Third Party (Supplier/ Subcontractor) Audit program to ensure conformance with GMPs and related regulatory requirements.
• Conduct the Periodic Review of Products
• Develop, periodically review and update of Sygen’s Quality Compliance Plan.
• Review and monitor Sygen’s Quality Control Plans to ensure the processes and procedures support the effective transfer of information within Sygen.
• Designing and managing control systems to deal with compliance violations.
• Keeping abreast of regulatory developments within or outside of the company as well as evolving best practices in compliance control.
• Ensuring company compliance with external regulatory bodies (state, federal and international) as appropriate (NAFDAC, PCN, PMGMAN, WHO, ISO etc.).
• Provision of Site Inspection Readiness Training for employees.
• Generate the plant/equipment and products lists for appropriate validation/revalidation schedule and periodic audit in accordance with Validation Master plan & cGMP guidelines.
• Where appropriate, advise on necessary changes, implementation and training on tools and techniques to enable others to achieve quality standards.
• Any other duties as assigned by the Head, Quality or General Manager Technical Operations

Qualification & Experience 

• Bachelor’s /HND degree in Pharmacy, Sciences (Industrial Chemistry, Chemistry, Biochemistry, Microbiology) or any related discipline
• Relevant qualification in Quality Management or proven experience in managing pharmaceutical compliance/demonstrable relevant experience of working in a similar role.
• Minimum of 8 years’ work experience with at least 3 years in a similar role, managing the Quality Assurance aspects of complex cross functional production processes.
• Qualified to a minimum of lead auditor level in a relevant discipline
• Experience in project management, Problem solving and Root Cause Analysis.
• Effective communication within team and with stakeholders
• Sound Technical knowledge, Smart, bold, and energetic
• Ability to read, analyze and interpret business and regulatory requirements
• Appreciation of other work disciplines, such as engineering, Procurement and Logistics.
• Strong interpersonal skills – ability to work collaboratively with functions and engage senior level resources in achieving the organizations’ people agenda
• Excellent judgment, deep personal ethics, and integrity

Key Competence 

• Smart, bold and energetic
• Owner mindset / Intrapreneurial – self-motivated and proactive with a practical and flexible approach to getting the job done
• Out of the box thinking with an ability to constantly improve
• Proactive- and able to anticipate business unit needs and identify talent issues before they negatively impact the business
• Strategic thinker - able to demonstrate understanding of the business and needs of individual business units
• Analytical and meticulous with a strong attention to detail – ability to assess workplace issues, processes, and employee performance, and use the information / data to develop strategies to resolve issues, improve efficiency and improve employee performance.
• Team builder - with the ability to lead, motivate and manage people to optimize performance and effectiveness.
• Strong relationship manager - able to manage relationships with both internal and external stakeholders.