Skill Set for QA Manager (Pharmaceutical Company)
1. Technical Knowledge:
Good Manufacturing Practices (GMP): Comprehensive understanding of GMP regulations and guidelines.
Regulatory Compliance: Knowledge of regulatory requirements and standards (., FDA, EMA).
Quality Control (QC) Processes: Proficiency in developing and implementing QC tests and procedures.
Validation and Qualification: Expertise in validation processes (., equipment, process, cleaning validation).
Documentation: Ability to maintain accurate and thorough QA documentation, including SOPs and batch records.
2. Analytical and Problem-Solving Skills:
Root Cause Analysis: Ability to conduct thorough investigations to identify the root cause of quality issues.
Risk Management: Proficiency in risk assessment and management techniques.
Data Analysis: Strong skills in analyzing QC test results and other data to make informed decisions.
3. Leadership and Management:
Team Leadership: Ability to lead, mentor, and develop a QA team effectively.
Project Management: Skills in managing projects, timelines, and resources efficiently.
Decision-Making: Capable of making sound decisions under pressure and in a timely manner.
4. Communication and Interpersonal Skills:
Written Communication: Strong skills in writing reports, SOPs, and other QA documentation.
Verbal Communication: Effective communication skills for presentations and interactions with regulatory bodies, management, and cross-functional teams.
Interpersonal Skills: Ability to build and maintain positive relationships with colleagues, regulatory authorities, and other stakeholders.
5. Attention to Detail:
Accuracy: Ensuring all QA activities and documentation are accurate and precise.
Thoroughness: A meticulous approach to quality checks, audits, and compliance activities.
6. Continuous Improvement:
Innovation: Ability to identify areas for improvement and implement innovative solutions.
Best Practices: Keeping