Avantor BSc, MSc Chemistry Quality Assurance Job Opening – Apply Online

t-align: center;">Avantor QA Jobs Chemistry – Apply Online For Executive Role

Senior Executive, Quality Assurance

Locations: Panoli, IND

Time Type: Full time

Posted on: Posted 3 Days Ago

Job Requisition ID: R-156068

The Opportunity:

The Sr. Officer- Quality Assurance is responsible to ensure that customer and regulatory requirements have been met by inspecting products and review of documentation throughout all aspects of the production process. Also to ensure compliance with all applicable standards and regulations, Good Manufacturing Practices (cGMPs), and Good Documentation Practices (GDPs). Provide Event and Complaint investigation support to other team members.

What we’re looking for:

• Education: Bachelor’s degree in Chemistry, Biology, or related field. Master’s degree is a plus.
• Experience: Minimum 5 years of experience working in quality assurance or related role within the pharmaceutical, biotechnology, or chemical industries.
• Knowledge of ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11, ISO 17025, or EXCiPACT standard is preferred
• Demonstrated experience or knowledge in conducting root cause analysis as it relates to non conforming material investigations
• Knowledge and experience utilizing Microsoft Outlook, Word, Excel, and Access, or equivalent software packages

How you will thrive and create an impact:

• Investigation – Performs real-time risk assessment and sufficiently controls suspected non‑conforming finished products, raw materials, and/or packaging components. Provides Event and Complaint investigation support to other team members. Provides oversight to ensure appropriate segregation of non-conforming material and resolution to product to resolve customer product pipeline.
• Validation – Supports equipment and product validation activities. Utilizes validation knowledge when assessing risk associated with internal events.
• Training – Provides initial training to new QA Inspectors; assists other departments with necessary training that pertains to functional aspects of the Quality Management System (QMS). Develops, maintains, and routinely evaluates on-boarding requirements for QA Inspectors.
• Audits – Leads Internal QMS Audits, conducts effectiveness audits, supports external customer and regulatory audits, and manages the Line of Sight / On the Floor Audit Program. Manages quality compliance on the production floor and is responsible for the communication and resolution within production areas with operations management.
• Scheduling – Coordinates daily and weekend QA coverage to support production activities.
• Batch Record Review and Release – Assists with the review and release of batch records as needed to support on-time delivery; ensures GDP compliance.
• Provides coaching and mentorship to QA Inspectors, and is the initial point of contact for production issue resolution.
• Complies with company policies, procedures, work instructions, and training requirements focusing on customer service, production, and quality.
• Keeps customer interests and regulatory requirements in mind, ensures customer needs are met by reviewing order requirements, customer documentation requirements, proper filling and assembly requirements, and, where needed, ensures other technicians understand and follow documented VWR procedures and GMP requirements.
• Ensures customer requirements are met.
• Verifies adherence to policies, procedures, and work instructions.
• Reviews production documentation for accuracy, completeness, and GDP compliance.
• Assists in correcting order issues and ensures actions that are taken are appropriate.
• Communicates issues / concerns to area owner and direct manager.
• Ensures actions taken to resolve production issues and concerns are effective.
• Ensures that the area is in a state of “audit readiness” at all times.
• Performs inspection tasks by following established work instructions and procedures, by using required tools and methods and; when applicable, equipment, to determine acceptability of product, components, and documentation.
• Performs pre-fill, in-process, and final inspections with the aid of documented work instructions and inspection information as required.
• Stops production when a non-conformance (NCM) is observed and follows appropriate NCM procedures.
• Documents non-conformances following applicable AMRESCO / VWR Solon procedures and work instructions.
• Documents and trends any quality production issues discovered during the course of inspection duties.
• Ensures cleanliness of work areas during the inspection processes.
• Initiates change requests to order documentation (bills of material) to resolve future production issues when necessary.
• Assists in the development and implementation of corrective and / or preventive actions.
• Utilizes problem solving tools such as 5M+E, 5 Why’s, or other root cause analysis tools / methods to identify and permanently resolve issues.
• Adheres to AMRESCO / VWR Solon’s QMS and VWR Policies, where applicable.
• Walks the floor to observe, train, and facilitate / support change.
• Performs other duties as assigned.

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