北京招聘

岗位职责：
?Oversees cGMP/GMP Compliance for all FDA/CFDA related production activities and associated documentation; including but not limited to: Batch Manufacturing, Engineering, Validation, Maintenance, Calibration, etc.
?Disposition (Release/Reject Decision) on all In-process Materials, Bulk Products and Finished Products.
?Oversee the Management of both the Supplier Qualification and Internal Audit Programs.
?Management of QA Operations and Regulatory Compliance Teams.
?Oversight and management / maintenance of cGMP manufacturing and/or manufacturing related documentation integrity for executed Quality Records
?Participation in and/or management of Operational / Operations related Quality Systems Improvement Projects as assigned.
?Ownership of the Investigations, CAPA, Deviation Systems.
?Responsible for the FDA cGMP & CFDA GMP compliance training for operations and operational support groups/teams. And, overall QA team member development.
?Assist management with participation in on-site regulatory agency and/or compliance audits. Primary Quality Contact for CFDA inspection-related activities.
?Other related duties as assigned by supervisor. 任职资格的具体描述：
?Bachelor Degree or above in Pharmaceutical/ Chemical/Pharmacy or related;
?At least 10 years plus professional experience with management responsibilities within pharmaceutical Quality Assurance.
?Experience in the management of, development of and motivation of a multi-level-skilled QA Team in Team based environment.
?Good working knowledge of US FDA cGMP & CFDA GMP Manufacturing Regulations for Pharmaceutical products.
?Solid compliance leadership and team mentoring skills, demonstrated by the ability to influence decisions, build consensus, plan, organize and communicate in a dynamic cross-functional environment.
?Solid problem solving skills.
?Attention to detail and ability to follow-through on commitments.
?Strong management skill and leadership
?Goal/tas- oriented, strong sense of urgency organized and team leader.
?Strong communication skills in both written and verbal.
?Fluent English and Mandarin.

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