Specialist - QC

Job Summary/Main Purpose

To perform chemical and physical analysis of raw materials, semi-finished products, and stability samples in accordance with approved specifications, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP).

Responsible for ensuring accurate analytical testing, maintaining laboratory documentation and data integrity, operating QC laboratory equipment, and supporting quality management system activities to ensure compliance with applicable regulatory requirements and company quality standards.

To contribute to the efficient operation of the Quality Control laboratory by maintaining high standards of quality, safety, compliance, and continuous improvement.

Main Responsibilities

• Perform chemical and physical analysis of raw materials, semi-finished products, and stability samples in accordance with approved analytical methods, specifications, and SOPs.
• Operate QC laboratory equipment, including HPLC, GC, UV-Vis spectrophotometers, dissolution apparatus, and other analytical instruments as applicable.
• Ensure all analytical testing activities are performed accurately and within established timelines, in compliance with GMP, GLP, and regulatory requirements.
• Ensure tested products meet established quality specifications and applicable pharmacopoeial standards, including USP, EP, and BP.
• Maintain accurate and complete records of analytical results, laboratory observations, and testing activities in accordance with Good Documentation Practices (GDP).
• Enter analytical results and relevant laboratory data into SAP accurately and on time.
• Ensure compliance with data integrity principles and ALCOA+ requirements across all laboratory activities.
• Support analytical method validation and method transfer activities as required.
• Handle and support Quality Management System (QMS) activities, including CAPA, AMS, and Change Controls through the AmpleLogic system.
• Participate in internal and external audits, provide required laboratory documentation, and support timely closure of audit observations.
• Strictly follow approved SOPs, laboratory safety procedures, and company quality policies.
• Maintain laboratory cleanliness, hygienic working conditions, and proper handling of laboratory materials and equipment.
• Assist in troubleshooting analytical issues and resolving day-to-day laboratory operational challenges.
• Ensure daily laboratory operations comply with Environmental Management System (EMS) and Environmental, Health, and Safety (EHS) standards.
• Use appropriate Personal Protective Equipment (PPE) and follow safe laboratory practices to minimize workplace hazards and operational risks.
• Identify, report, and support the prevention of environmental impacts and safety risks associated with laboratory activities.
• Participate in EHS activities, audits, and continual improvement initiatives.
• Coordinate effectively with Quality Assurance, Production, R&D, and other relevant departments to support quality and operational requirements.
• Support QC supervisors and designated personnel in assigned laboratory and departmental activities.
• Contribute to continuous improvement initiatives aimed at enhancing laboratory efficiency, analytical accuracy, quality compliance, and operational performance.
  
  

Core Competencies (Skills, Knowledge and Attitude)

• Bachelor's degree in Pharmacy, Chemistry, or a related Science discipline.
• Minimum 3–6 years of relevant experience in pharmaceutical Quality Control.
• Strong technical knowledge and hands-on experience in HPLC, GC, UV-Vis spectrophotometry, dissolution testing, and other pharmaceutical analytical techniques.
• Sound knowledge of GMP, GLP, SOPs, and applicable regulatory guidelines, including USP, EP, and BP.
• Experience in analytical method validation, method transfer, and assay analysis.
• Strong understanding of data integrity principles, ALCOA+ compliance, and Good Documentation Practices.
• Working knowledge of Quality Management System activities, including CAPA, AMS, Change Controls, and audit compliance.
• Proficiency in SAP, AmpleLogic, and computer software applications.
• Ability to maintain accurate laboratory records, analytical results, and test reports.
• Strong analytical, troubleshooting, and problem-solving skills.
• Excellent attention to detail and commitment to quality and regulatory compliance.
• Effective written and verbal communication skills.
• Ability to work collaboratively with cross-functional teams, including QA, Production, and R&D.
• Strong organizational and time-management skills with the ability to manage multiple tasks and priorities.
• Highly disciplined, accountable, and responsible, with a strong sense of ownership.
• Self-motivated, adaptable, and willing to learn and implement new technical knowledge.
• Strong commitment to laboratory safety, environmental protection, and continuous improvement.