Quality Operations CCP Trainee

Transform Lives Through Excellence in Quality Control

At Sanofi, we deliver 4.3 billion healthcare solutions to people every year, transforming the practice of medicine through breakthrough science that improves people's lives. Our Manufacturing & Supply teams ensure this impact through flawless planning and meticulous attention to detail. With your expertise in Quality Control, you'll help us protect more people from infectious diseases and bring hope to patients and their families worldwide.

About the Job

Overview:

• The Quality Operations CCP Trainee shall be trained and responsible for providing Quality oversight and advice to the site GMP Operations team (e.g. manufacturing, engineering & maintenance, quality control and process development departments) to ensure that the site operations meet Sanofi global quality standard requirements and fulfil the applicable regulatory expectations.

• The Quality Operations CCP Trainee will be trained and experienced in solving problems, possess strong understanding of GMP operations and well-versed in multiple quality systems including deviation management, change controls, deviations/CAPAs, laboratory investigations, document management system, batch disposition and analytical method and equipment qualification.

• The Quality Operations CCP Trainee will partner closely with the site GMP operations team in solving complex problems to ensure quality, safety, reliability, efficiencies as well as manage multiple quality systems including, but not limited to change controls, deviations, laboratory investigations and CAPAs. Additionally, he/she will also manage the site process for Change Control and Batch Disposition/Release.

Main Responsibilities:

• Be the subject matter of expert in performing batch/cleaning record review of the manufactured batches i.e., active pharmaceutical ingredients and intermediates in a timely manner by ensuring all the quality aspects of the batches are compliance with GMP requirements. Manufactured batches that are implicated by Deviation/OOS/OOT/ILI which will potentially impact batch disposition/release decision will need to be scientifically sound to withstand scrutiny during the batch review/disposition/release decision.

• Independent review and approve QA operational and investigational documents and/or relevant records i.e., operational procedures, deviations and CAPAs with compliance to GMP and prevailing regulatory requirements.

• Monitor the progress of effective corrective and preventive (CAPA) actions to ensure timely closure of CAPA. Collaborate with site operation on problem prevention activities and system improvements.

• Participate actively in the GEMBA walk-down during investigation to triage and resolve on-the-floor manufacturing issues.

• Participate in the improvement projects by ensuring the validation/qualification are execute in conformance with GMP e.g., review of validation/qualification protocols and reports. Support OpEx improvement projects.

• Training: Performing GMP related trainings

• Facilitate the daily level 2 quality meeting. Backup for Quality team.

• Play a pro-active role by complying and adhering to HSE guidelines. Embrace always Zero Incident Mindset and adopt the responsibility of HSE protection policies and Life Saving Rules (LSR).

• Support the preparation and trending of data trend analysis during the quarterly GMP review.

• Conduct self-inspections of facilities, operations, and procedures to ensure conformance with GMPs, and related regulatory requirements. Support in the general manufacturing activities in audits and regulatory inspections.

• Other responsibilities that are not included in the above but are related to quality assurance and in accordance with internal guidelines and SOP.

Requirements/Qualifications:

• Good understanding of QA Operations and process technical knowledge in areas of quality operations and manufacturing will be an advantage.

• Sound knowledge of GMP of pharmaceutical industry, Global Quality policies, health authority regulations and data integrity requirements governing laboratory operations.

• Familiarity with batch disposition process using SAP system.

• Proficient in QMS and Quality Risk Management Principles. Good understanding of risk-based decision framework

About You

Education:

• Bachelor’s degree in chemical engineering, pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or engineering with at least 2-3 years of quality operation experience working in the pharmaceutical industry in areas such as manufacturing, validation and engineering.

Soft Skills:

• Excellent verbal and written communication skills; effective communication and presentation skills across different levels of the organization, including senior management and execution levels.

• Discipline and assertiveness in the decision-making and execution of quality related issues. Able to work independently and write reports. Strong interpersonal relationships in establishing good partnerships necessary for the development of an engrained Quality culture and the correct execution in transverse.