Job SummaryUnder broad supervision, conducts internal quality controls to ensure established quality procedures and norms are followed.
Conducts non-routine quality analysis and tests / inspections of a quality control program, resolving most questions and problems and recommends necessary quality procedure changes.
Monitors and records inconsistencies with quality procedures and norms. Records and analyzes customer claims and prepares reports on rejected or defective products.
May assist in the development of new methods and procedures. Responsible for coordinating and independently managing projects.
1. Responsibility for management of stability samples, including : - management of stability chambers qualification status - supervision under stability samples schedule - management of stability protocols and reports 2.
QA batch release 3. Support in resolving QA issues 4. Preparation of SOP's and or instructions in the area of responsibility Provides information, support, and guidance to team within the scope of the functional unit.
Assists with training / cross-training department personnel in area of specialty. Serves as a temporary backup to department personnel if the need is determined by supervisor.
May lead meetings of cross-functional teams related to projects. May assist in analyzing and improving department and functional unit procedure and policy.
Responsible for electronic data entry as well as updating and distribution of QA forms. Assists with generation and maintenance of quality documentation.
May assist with material release functions that require focused attention to detail. May assist with movement of released material and product disposition documentation.
May generate variance reports or other product-related reports. May generate, review, or revise controlled documentation.
May edit and update various procedures and policies. May take part in and contribute to ISO 9001 audits and assist with ISO 9001 program documentation and implementation.
May act independently as the Qualified Person for product disposition, release or reject. Responsible for ensuring that each individual batch has been manufactured and tested in accordance with defined release procedures.
Interacts with various departments in communicating QA standards. Must be regular and punctual in attendance Responsible for maintaining quality within the scope of the job description.
SUPERVISORY RESPONSIBILITIES Assists in training of department personnel. EDUCATION and / or EXPERIENCE Master's degree in chemistry / master's degree in pharmaceutical chemistry / two years of experience in QA at an ISO registered company.
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