5+ years of experience in a highly regulated pharmaceuticals industry or related field
Demonstrated experience with qualification of commercial processing and packaging equipment
Proven track record of managing projects from start to finish on time and on budget
Strong understanding of cGMP and regulatory standards for validation
Experience in writing and reviewing SOPs and compliance protocols.
Responsibilities
Assure facility and Laboratory equipment meet cGMP standards
Author, approve, and execute qualification protocols and reports
Plan and manage qualifications, calibration, and maintenance of equipment
Support procurement of equipment and qualification of selected vendors
Maintain and improve the validation master plan for the site
Present qualification studies to regulatory and client auditors
Provide technical guidance on qualification policies and procedures
Benefits
Opportunities for professional development and training
Collaborative work environment with a strong quality focus
Exposure to cutting-edge pharmaceutical technologies
Potential for advancement within the organization
Full Job Description
RESPONSIBILITIES:
Assists in assuring facility, manufacturing, packaging, and Laboratory equipment are qualified to the required cGMP standards.
Authors/approves and executes qualification protocols and reports.
Schedules, plans, manages performance qualifications, calibration and maintenance of equipment and utility systems and laboratory Instruments in coordination with operations, Quality Control and maintenance.
Assists sourcing and procurement of facility equipment and Laboratory Instruments through completion of following tasks
Qualification of Vendors Selected.
Input to the development of the URS/FRS/DDS.
Assists with the routine calibration and maintenance of the Validation Master Plan for the site.
May present qualification studies to Regulatory and Client Auditors as required.
Assists with the design, maintenance, and continual improvement of the qualification system in line with cGMP standards.
Provides technical expertise and guidance on qualification policies and procedures and the implementation of those within the Production and Quality functional areas.
Occasionally supervises specialized contract personnel and outside vendors in the performance of contract services.
Summarizes studies and authors qualification reports in compliance with the cGMP standards and in a timely manner.
Develops and executes matrix type validations where applicable for processes and equipment with adequate supporting rationales.
Initiates and investigates exception reports and non-conformances, associated with the qualification studies. Troubleshoots and resolves technical issues.
Other responsibilities and special projects will be assigned based on business and customer needs.
QUALIFICATIONS:
Bachelor's degree in sciences or engineering
5+yearsexperiencein a highly regulated pharmaceuticals industry or related field
Demonstrated experience with qualification commercial processing a packaging equipment.
Proven track record of managing projects from start to finish on time and on budget.
Strong working knowledge of cGMP and regulatory standards for validation.
Experience in writing and reviewing SOPs, GMPs, governmental regulations and/or protocols for accuracy, traceability and compliance.
