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Form of workPosition Summary
In an efficient and effective manner, this position will review executed batch records and ensure that customer requirements are met in accordance with release specifications.
Coordinates the execution of Annual Product Reviews according to SOP’s and/or customer specified requirements.
Create and Maintain compatibility for new customer products
Expectations and Responsibilities
Understand and follow all company policies and procedures, safety requirements, cGMP regulations and customer requirements applicable to this position.
Perform reviews and approvals of executed batch records.
Perform product final release and provide the customer with required documents.
Responsible for Non-Compliance Reporting follow-up tracking and report closures, documentation archive, and compile batch record dockets.
Review batch records for conformance to customer requirements, conformance to specifications, and completeness of information and compliance with regulatory requirements.
Proficient in QCBD Quality Assurance functions.
Follow up and locate missing or incomplete information. Communication with customers in resolving batch record concerns.
Completes assigned Annual Product Reviews in accordance with KIK SOP’s and/or customer specified requirements.
Provide all necessary documents for customer audits in a timely fashion and attend as requested.
Other tasks as assigned
Minimum Education and Experience
High School diploma plus vocational certification or equivalent experience.
