Associate Manager-Quality Control at Shalina Healthcare

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.