Associate Manager-Quality Control
Job Description
- The Quality Control Associate QC Manager is responsible for overseeing all quality control activities within the pharmaceutical manufacturing facility.
- This includes ensuring that raw materials, in-process products, and finished goods meet established quality standards and regulatory requirements.
- The role ensures compliance with Good Manufacturing Practices (GMP), regulatory guidelines, and company quality policies.
Key Responsibilities
- Manage and supervise all Quality Control laboratory operations, including chemical, microbiological, and instrumental analysis.
- Ensure testing of raw materials, packaging materials, in-process samples, and finished products in accordance with approved specifications and methods.
- Review and approve laboratory results, certificates of analysis (CoA), and test reports.
- Ensure compliance with regulatory requirements such as GMP, GLP, WHO, NAFDAC, and other applicable standards.
- Oversee calibration, qualification, and maintenance of laboratory equipment.
- Lead investigations on Out-of-Specification (OOS), Out-of-Trend (OOT), and deviations, and ensure proper documentation and closure.
- Develop, review, and update Standard Operating Procedures (SOPs), specifications, and test methods.
- Coordinate stability studies and ensure proper documentation and reporting.
- Manage and mentor QC staff, including training and performance evaluation.
- Ensure proper documentation practices and data integrity in line with regulatory expectations.
- Support internal and external audits, including regulatory inspections.
- Collaborate with Production, Quality Assurance, and other departments to ensure product quality and compliance.
- Monitor laboratory inventory and ensure availability of reagents, chemicals, and consumables.
Qualifications & Requirements
- Bachelor’s Degree in pharmacy, Chemistry, Biochemistry, Microbiology, or related field (Master’s Degree is an advantage).
- Minimum of 10–15 years of experience in pharmaceutical manufacturing, with at least 3–5 years in a managerial role.
- Strong knowledge of GMP, GLP, and regulatory requirements (e.g., NAFDAC, WHO).
- Experience with analytical instruments such as HPLC, GC, UV Spectrophotometer, etc.
- Strong leadership, organizational, and problem-solving skills.
- Excellent communication and report-writing skills.
- High attention to detail and commitment to quality.
Key Competencies:
- Leadership and Team Management
- Analytical and Critical Thinking
- Regulatory Compliance
- Attention to Detail
- Decision-Making Ability
- Time Management.
Method of Application
Interested and qualified? Go to Shalina Healthcare on myshalina.darwinbox.com to apply
