Supervisor, QA
7 months ago
**Job Summary**:
To supervise activities related to quality assurance and control in order to ensure timely and effective implementation of all company policies, procedures and activities involved in assuring the quality of manufactured products.
- Supervises and directs quality assurance technicians/auditors who are responsible for enforcing Good Manufacturing Practices and other quality-related polices in order to meet product quality standards
- Reviews Production Batch Records and other manufacturing-related documents to verify compliance and record keeping for all mandated manufacturing processes, quality checks, testing, sampling and sanitation activities
- Audits quality control of raw materials, packaging components, labels and finished products to ensure compliance with established specifications and regulatory standards
- Follows up with implemented programs to ensure compliance by all employees and other personnel in the manufacturing facility
- Coordinates testing results involving finished products, raw materials and packaging components in order to assist in the appropriate release and hold programs associated with these materials
- Collaborates with other departments to assist in investigating and correcting quality-related issues.
- Presents proactive recommendations and offers solution to quality management to improve quality and work efficiency
- Assists in the implementation of operation procedures, quality systems and programs in order to ensure proper testing, evaluation, inspection and technical support that meet product quality standards
- Participates in all regulatory, third party and customer audits and inspection in order to provide corrective action responses when needed
- Mentors, trains, sets expectations, provides accountability and performs evaluations in order to ensure good performance by quality assurance technicians/auditors
- Provides individual and team information on quality issues in the form of reports/statistics to support decision making and reporting at a higher level.
**Job Qualifications**:
- Bachelor’s degree in Pharmacy or Science.
- Minimum Experience: 5-7 years of experience in the pharmaceutical industry for solid/sterile.
**Technical Skills**:
- Aware of Quality management system
- Knowledge of guidelines related to pharmaceutical manufacturing.
- Aware of EDA requirements.
- Batch review and release.
- Previous experience in IPC activities during manufacturing.
- Handling and reviewing of deviations.
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