MANAGER, QUALITY ASSURANCE
LGM Pharma
RESPONSIBILITIES:
- Supervise the daily activities in the warehouse to ensure efficient flow of materials and timely completion of Quality Assurance duties.
- General oversight of systems for labeling, GMP training, compliance, document control, information tracking, and equipment calibration.
- Lead investigation activities perform root-cause analyses and develop corrective and preventative action plans.
- Assist in internal and external audits and inspections.
- Develop and maintain appropriate document storage and retrieval systems.
- Assist with the review and approval for original and/or revised Quality Operation Processes, and GMP documentation.
- Use of statistical process control to evaluate trends and provide periodic KPI trend reports to senior management as required.
- Assure timely closure of audit items.
- Provide reports from QA and data to support other business functions, as needed.
- Ensure Deviations, CAPA and Change Controls are managed in a timely manner.
- Support the customer complaint process and respond to Customer complaints as required.
- Performs other related duties as required.
- Supervise and mentor junior staff members and other related duties as required.
- Comply with cGMP regulations and all standard operating procedures.
- Bachelor's degree in a scientific discipline.
- 10+ years of experience in Quality Assurance in a GMP regulated manufacturing environment, or equivalent combination of education and experience.
- 5+ years of experience leading or supervising others in a GMP regulated manufacturing and distribution environment preferred.
- Ability to read and interpret technical procedures, SOP's, GMP's and governmental regulations.
- Strong communication skills, both written and verbal.
- Ability to organize, prioritize and effectively perform concurrent tasks with minimal supervision.
- Strong attention to detail.
- Experience in ICH Q7, 21 CFR Part 11, 21 CFR 210 and 211
- ASQC quality certifications, ISO 9000 or other Audit training preferred.
Vacancy posted 2 days ago
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