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