Quality Engineer

Title:

Quality Engineer

Job Summary

The Quality Engineer – Pharmaceutical is responsible for ensuring that pharmaceutical products, processes, and systems comply with GMP, regulatory requirements, and internal quality standards. The role focuses on process improvement, deviation management, CAPA, validation support, and risk management to ensure product quality and patient safety.

Key Responsibilities

Quality Systems & Compliance

• Ensure compliance with cGMP, FDA, EMA, WHO, ICH, and local regulatory requirements
• Support and maintain the Quality Management System (QMS)
• Participate in internal, external, customer, and regulatory audits
• Ensure data integrity and documentation accuracy

Deviation, CAPA & Change Control

• Investigate deviations, non-conformances, OOS/OOT, and customer complaints
• Perform root cause analysis (e.g., Fishbone, 5 Whys)
• Develop, implement, and track Corrective and Preventive Actions (CAPA)
• Review and approve change control requests

Process & Product Quality

• Monitor manufacturing and quality processes to ensure consistent product quality
• Identify process improvement opportunities using risk-based approaches
• Support process validation, cleaning validation, and equipment qualification
• Review batch records and ensure right-first-time execution

Documentation & SOPs

• Review, approve, and maintain SOPs, protocols, and reports
• Ensure proper documentation practices in line with ALCOA+ principles
• Support training activities related to quality procedures

Supplier & Material Quality

• Support supplier qualification and audits
• Review material quality issues and supplier CAPAs
• Ensure compliance of raw materials, packaging, and components

Qualifications

Education

• Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Biotechnology, Life Sciences, or related field
• Master’s degree preferred (but not mandatory)

Experience

• Experience in Quality Engineering or Quality Assurance in a pharmaceutical environment
• Experience with regulated manufacturing (oral, injectable, biologics, etc.) preferred

Required Skills & Knowledge

• Strong knowledge of GMP and pharmaceutical regulations
• Hands-on experience with deviations, CAPA, change control, and audits
• Familiarity with risk management tools (FMEA, HACCP)
• Understanding of validation and qualification principles
• Excellent analytical, documentation, and communication skills
• Ability to work cross-functionally with Production, QC, Engineering, and Regulatory teams