QA Manager - Puniska Injectables - Goa Branch

Role & responsibilities

1. Regulatory Compliance Expertise
• Profound knowledge of pharmaceutical regulatory standards (e.g., FDA, EMA, WHO, ICH guidelines).
• Expertise in ISO standards such as ISO 9001 (Quality Management Systems)
• Experience with cGMP (current Good Manufacturing Practices) and GLP (Good Laboratory Practices).
2. Quality Management System (QMS) Development
• Proficient in designing, implementing, and maintaining QMS frameworks.
• Familiarity with QMS software tools for document control, CAPA management, and audit tracking.
3. Risk Management
• Expertise in risk assessment methodologies like FMEA (Failure Mode and Effects Analysis) and HACCP (Hazard Analysis and Critical Control Points).
4. Audits and Inspections
• Skilled in conducting internal and external audits, including vendor/supplier audits.
• Experience in hosting regulatory inspections and addressing findings with effective CAPA plans.
5. Documentation and Record Management
• Strong skills in document control, including drafting, reviewing, and approving SOPs, protocols, and quality manuals.
• Proficient in electronic document management systems (EDMS).
6. Change Management
• Expertise in managing change control processes to ensure compliance with quality and regulatory standards.
7. Deviation and CAPA Management
• Experienced in identifying, investigating, and resolving deviations.
• Skilled in implementing robust CAPA systems for continuous improvement.
8. Training and Development
• Ability to develop and deliver training programs for staff on QMS, GMP, and other quality-related topics.
9. Analytical and Problem-Solving Skills
• Skilled in analysing trends from quality data and implementing corrective actions.
• Proficiency in using statistical tools for quality metrics (e.g., Six Sigma, Lean methodologies).
10. Leadership and Collaboration
• Strong leadership skills to manage cross-functional teams.
11. Good knowledge of word/excel/PPT/different quality mapping tools

Preferred candidate profile

B.Pharm/M.Pharm - QA with more than 10 years of Experience in regulated Plant Quality Assurance

Perks and benefits