Job title: Sterile Compounding Expert
- Location: Beijing
About the job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Sterile Compounding Expert within our M&S China-BEI Site, will be to making best class medicines with excellent strategies and tools and delivering them to our patients.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main responsibilities:
Please indicate here the main job responsibilities.
Generic
- Continuously improve the compliance level of sterile production, attend and promote SMS execution, Lean manufacturing.
Continuously improve the regulatory compliance and quality assurance level of sterile production, participate in and promote the in-depth implementation of the Sanofi manufacturing system and lean production within the department.
- Organize, coordinate, track and implement of deviations, changes, validation, complaints and global standards gap analysis etc.
Organize, coordinate, follow up on and implement deviations, changes, validation, complaints and gap analysis against global standards.
- To ensure the continuous process compliance improvement through the management of quality systems.
Ensure continuous improvement of process compliance through the management of quality systems.
- To ensure the implement of quality policy/objectives of Sanofi and to ensure the quality compliance of sterile production operation.
Implement Sanofi’s quality policy and quality objectives, and ensure the quality compliance of sterile production operations.
- To ensure effectiveness of sterile production quality improvement programs/projects.
Ensure the effectiveness of sterile production quality improvement programs and projects.
KEY ACCOUNTABILITIES
- Lead continuous improvement work on sterile compounding PCU.
- Organize, coordinate, track and execute sterile compounding related investigation of deviations, complaints and correction actions, keep close communication with quality to improve the investigation compliance level.
- Participate in and lead sterile production related changes, guarantee the change compliance through regulation understanding.
- Establish and assure a continuous GMP training to maintain an high level of GMP awareness in all the staff.
- Be familiar and enhance global standards understanding, lead sterile production related gap analysis and implementation.
- undefined
- Coordinate the validation execution of process, equipment, cleaning and execution according to the master plan.
- Monitor production environment, process, hygiene, facilities and personal behaviour and make proposal for improvement, to make sure the activities comply with SOP requirements.
- Lead and coordinate department resource to attend self-inspection, authorities’ inspection and global quality audit.
- Manage procedures to correct deviations and out of specification results and monitor the corrective and preventive actions (CAPA) to prevent the repetition of the not compliance instance.
- Ensures quality risks are properly managed (identification, assessment, control, communication).
- Assure the correct handling of product recall and customer complaints.
- Ensure effectiveness of gap analysis process.
- Involve site quality improvement projects/programs (compliance program, QMI, DIMM etc) to ensure the effectiveness of project/programs.
- Participate in process optimization, equipment improvement and technique innovation to sustainably improve OEE and yield, participate in SMS standards deep execution and continuously improve in 5S/HSE aspects and waste minimization.
- Other tasks temporarily assigned by department manager.
Sterile production Department HSE Responsibilities
➤ Responsible for following the company’s HSE policy and integrated all requires into daily job.
➤ Incorporate HSE work into the work plan.
➤ Organize the implementation of HSE management target plan of this department, implement HSE rules and regulations, HSE operation procedures and HSE technical action plan.
➤ Regularly carry out to identify HSE potential hazards and develop action plan and finish on time.
➤ Timely working out of employee opinions.
➤ Actively cooperate with HSE management to prevent accidents happens.
➤ Regularly carry out +QDCI meetings at all levels considering HSE8 requirements. Feedback HSE issues in a timely and accurate manner, and actively implement remediation.
➤ Participate in the investigation for accidents, analyze the root causes of accidents from the quality management perspective, and related CAPA.
➤ Responsible for design annual department PASS plan and ensure implementation as planned.
Sanofi (Beijing) Pharmaceutical Co., Ltd. Energy Policy: "Quality as the top priority; through technical means, behavioral standards and human awareness, continuously reduce the energy consumption share in product value, benefit users, and promote company development." Good awareness of energy conservation is required, participate in energy saving actions, and assist in the continuous development of the energy management system.
➤ Actively propose energy-saving projects
➤ Coordinate and support the development of energy-saving projects and give positive feedback
➤ Coordinate and participate in the implementation of energy-saving projects
➤ Participate in internal audit of energy management system
About you
List here ideally the must-haves criteria to be successful on the role.
At least a bachelor or above degree in pharmacy or biology disciplines with 3~5 years’ experience in quality or sterile area, experienced candidates in compounding process will be priority. Must be a committed "Quality or Sterile" professional with knowledge of quality systems within the pharmaceutical or related industry.
•Thorough understanding of manufacturing processes and aseptic processes
•Strong working knowledge of quality systems, regulatory requirements across multiple health authorities.
•Fluent English both in written and verbal
•Good communication skills
•Able to burden pressure
•Brave to make decision
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Pursue Progress. Discover Extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!