|REPORT TO: QA Manager
SUPERVISES/DIRECTS: QA Assistants and Support Staff as project or work conditions require.
Responsibilities include assistance of manufacturing QA related projects that vary in scope, complexity and size. Assist QA manufacturing activities to ensure compliance with current GMP’s and GLP’s.
Manage and maintain QA records (i.e. logbooks, equipment records, specifications, procedures).
Manage Change Control Order system.
Responsible for Record Retention activities associated with all GMP documentation maintained by Q.A.
Identifies and initiates quality improvements in systems and procedures.
Provides incoming and in-process support activities as required.
Responsible for ongoing review, design and implementation of cGMP standards.
Review all aspects of pharmaceutical manufacturing and identify any deficiencies.
Create/maintain/organize manufacturing staff GMP training records.
Supervise and maintain the deviation, investigation change control, SOP validation and batch record review systems.
Ensure the proper storage of controlled documentation (archives, back-ups).
Review, approve and maintain certifications related to products, manufacturing supplies, and calibration records.
Supervise the schedule for the calibration of manufacturing equipment. This includes scheduling and verifying the performance of the calibration.
Generate and prepare client batch record package, review batch record for completeness and accuracy.
Develop, modify and create new format of batch records depending upon products (clients) needs.
Review and approve completed job folder generated by receiving department.
Review technical information provided by client for formulation process and components capability which will be used for the preparation of the batch record.
Verify the proper storage condition for received material such as API (active pharmaceutical ingredient) and any other excipients.
Responsible for the release of all raw material and manufacturing supplies.
Issue and assign the proper tests required for in-process and final process testing to the analytical laboratory.
Audit the manufacturing supplies (critical components) retention against record, completeness and accuracy.
Responsible for the release of manufacturing area clearance for the initiation of new filling projects.
Supervise shipping of final product to clients.
Prepare batch record for various media fills.
Responsible for the accountability of the number of vials or syringes manufactured, shipped or retained.
Bachelor's Degree in chemistry, biology, or related scientific discipline and one (1) to year of experience in an Aseptic Manufacturing QA environment or closely related GMP/GLP environment.
Demonstrated competence in QA related activities through education and experience.
Demonstrated ability to work under minimum supervision; exhibit leadership skills to coordinate personnel and projects on various levels. Excellent oral and written communication skills are required.
|PYRAMID Laboratories, Inc.,|
State or Province