Quality Management (QA)
Description of duties:
1. Daily management work
2quality data analysis, comparison
3Review of product quality documents
4.Supervision and verification work
5Customer audit and self-examination inspection, rectification and follow-up work
62. Supervise and urge the person in charge of the workshop to formulate the training plan for new employees in the workshop and implement it as planned; Cooperate with the implementation to complete the annual GMP knowledge training organized by the department.
7Customer Complaint and Return Handling
8Investigation and handling of quality accidents
1. Bachelor degree or above, chemical pharmacy, chemical engineering and technology, pharmacy, chemistry related major;
2、5Years and above of oral solid preparation enterprise production, quality management experience; familiar with product process validation, equipment validation and cleaning validation;
3, familiar with ICH and GMP related regulations and quality management system, participated in FDAor GMP certification;
4, with good communication and organization and coordination ability; with cross-team collaboration, communication and coordination ability, excellent planning and execution ability.
System QA (analytical laboratory direction)
Description of duties:
1Responsible for OOS/OOT management, summary and trend analysis;
2Responsible for the drafting of quality system related documents, quality objectives related data summary;
3Responsible for organizing the collection and provision of external data, and the preparation and implementation of GMP certification declaration data;
4Responsible for the daily supervision of QC laboratory and GMP compliance inspection;
51. Review the laboratory documents and records, correct the filling errors in the records in time, and ensure that the registration declaration and release are not affected;
61. Review laboratory-related documents, verification/validation plans and reports, stability plans and reports, etc., and supervise the implementation of verification/validation and stability studies;
7Participate in the drafting and revision of laboratory monitoring and electronic data management related documents, and regularly track and spot check laboratory electronic data and system audit, track problem rectification, and ensure data reliability;
8Complete other temporary tasks assigned by superiors.
1. Bachelor degree or above, major in pharmacy, biology or related.
2、Good communication, organization and coordination, execution ability.
3, skilled application of office software; English CET-6 or above, proficient in English reading and writing is preferred; QC testing of solid preparations is preferred.
Contact email: firstname.lastname@example.org