Associate Manager-Quality Control

Shalina Healthcare

Remote

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