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standards, such as current Good Manufacturing Practices (cGMPs).
As part of the Technical Service team, your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations. You will continuously support qualification, data integrity, operation excellence and training in the production department, meanwhile to provide technical support for manufacturing robustness.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
1.1 Improve production efficiency and capacity. Ensure robust product quality. Continuously improve processes, equipment robustness, etc., to meet continuous changed needs.
2.1 Responsible for the documentation, implementation and training of production equipment and aseptic process validation according to the validation plan.
2.2 Responsible for qualification of related changes and deviation management
2.3 Ensure that the relevant documents are updated in a timely manner.
2.4 Ensure the maintenance of validator.
3.1 Support the investigation and research of production technology problems, evaluate the experimental results, and improve the process to ensure that the products and processes meet the requirements of customers.
3.2 Support the improvement and verification of new products and new processes, participate in the formulation of relevant verification strategies and programs, determine the relevant process parameters and revise relevant documents according to the verification conclusions
3.3 Support qualification of the filters and other production materials and their documentation.
3.4 Support the registration department and the quality department to complete the registration documents.
4.1 Be accountable for the team's understanding and performance of good data management and data integrity. Be a role model that supports a positive compliance culture.
4.2 Responsible for DI assessment, training, and information sharing of the department.
4.3 Responsible for the training of department, including job curriculum, and other training records management.
4.4 Responsible for CI specialist.
Qualifications
Must-Have
Bachelor's or above degree in pharmaceutical, biology, bio-chemistry or related major.
High sense of responsibility and subjective initiative, good communication skills and team spirit and analytical judgment ability
Demonstrated good oral and written communication skills in English
Good computer skills (MS Office, etc.).
Ability of continuously learn,
Nice-to-Have
Master's degree
1+ years of experience in pharmaceutical, especially sterile process and equipment operation.
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Manufacturing
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