Quality Assurance Manager at Nalis Pharmaceuticals Ltd

Job Overview

Location
Lagos, Lagos
Job Type
Full Time
Date Posted
9 months ago

Additional Details

Job ID
127577
Job Views
99

Job Description






Job Summary




  • The Quality Assurance Manager holds the critical role of ensuring that all pharmaceutical products meet stringent regulatory and internal quality standards. 

  • This role demands vigilance, scientific rigor, and leadership to maintain compliance with cGMP, WHO, NAFDAC, and international regulatory bodies. 

  • The QA Manager is the company’s final defense against compromise, safeguarding product integrity, patient safety, and company reputation.



Key Responsibilities

Quality Management System (QMS):




  • Develop, implement, and maintain QMS in alignment with regulatory standards (NAFDAC, WHO-GMP, ISO 9001).

  • Ensure continuous improvement of QMS through regular audits and management reviews.



Compliance & Documentation:




  • Oversee compliance with cGMP, GLP, and SOPs across production, QC, and packaging lines.

  • Ensure accurate and timely documentation, batch record reviews, deviations, and change controls.



Audits & Inspections:




  • Lead internal audits, host external audits (regulatory bodies, clients), and manage CAPAs.

  • Prepare the site for regulatory inspections and ensure timely closure of observations.



Process & Product Oversight:




  • Monitor validation of processes, cleaning, and equipment.

  • Oversee product release based on conformance to specifications.



Training & Leadership:




  • Train and mentor QA personnel and cross-functional teams on quality systems and cGMP updates.

  • Foster a culture of quality and ownership across all departments.



Vendor & Supplier Quality:




  • Evaluate and audit raw material suppliers and third-party contractors.

  • Ensure traceability and quality of materials throughout the supply chain.



Educational Qualifications




  • Bachelor’s Degree in Pharmacy (B.Pharm), Pharmaceutical Sciences, Microbiology, Biochemistry, or related field.

  • Advanced degrees (M.Sc., MBA) in Quality Management or Regulatory Affairs are an advantage.

  • Certification in ISO 9001:2015, Six Sigma, or cGMP is highly desirable.



Experience:




  • Minimum 5 - 7 years of relevant experience in QA/QC in a pharmaceutical manufacturing environment.

  • At least 2 years in a supervisory or managerial role.

  • Proven experience managing regulatory inspections and internal audits.

  • Familiarity with sterile and non-sterile production environments is a plus.



 Other Requirements:




  • Must be registered with relevant professional bodies (e.g., PCN, NAFDAC-recognised body).

  • Must be conversant with national and international pharmaceutical laws and regulations.

  • Must exhibit ethical integrity and professional discretion.

  • Flexibility to work extended hours when required.

  • Strong leadership presence and ability to make high-stakes decisions under pressure.



Required Skills and Competencies:




  • Deep knowledge of current Good Manufacturing Practices (cGMP), quality control principles, and pharmaceutical regulations.

  • Strong analytical and problem-solving skills.

  • High attention to detail and documentation accuracy.

  • Excellent communication and interpersonal skills.

  • Proficiency in Quality Management Software and ERP systems (e.g., Odoo, SAP, TrackWise).

  • Ability to lead under pressure and drive cross-functional coordination.

  • Root Cause Analysis (RCA) and risk management expertise.



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