Associate Manager, QA Biologics job opportunity at Roche.

Home Jobs In China Tag: QA Biologics Associate Manager, QA Biologics position at Roche


DatePosted 8 Days Ago bot
Roche Associate Manager, QA Biologics
Experience: 7-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

QA Biologics

Copy Link Report
degreeAssociate
loacation Shanghai, China
loacation Shanghai....China

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Principle Roles & Responsibilities / Accountabilities主要职责/责任 Quality and Technical Guidance Play the role of quality oversight, provide immediate support and guidance during the project phase and RCPT routine GMP operation, including but not limited imported DS material release, master manufacturing record establishment, aseptic filling & package operation oversight, quality evaluation on any issues or queries that may arise during product handling. Develop, review and maintain comprehensive quality documentation (manuals, SOPs), ensuring they comply with GMP/GDP/Roche requirements, are up-to-date, and accessible.  Evaluate new suppliers and service providers based on quality criteria and regulatory requirements, and collaborate during external/internal audits and health authority inspections. Perform thorough risk assessments to identify potential quality risks, develop and implement risk mitigation strategies Responsible for ensuring that product quality issues are correctly investigated, and that appropriate corrective and preventative actions are implemented. Review deviation/exception/ investigation reports,  Assure the efficient, timely, batch record review and CGMP compliant materials and products release. Support and represent QA during audits and inspections; may directly interact with regulatory agencies during on-site inspections. Maintain project timelines associated with initiatives to support the evolving business. Participate in tech transfer, collaboration with other functions to ensure the success of new product manufacturing. Support the compliance, regulatory and training activities as required,  Support the continuous improvement and oversight of QA Compliance programs and identifies and implements new technologies to improve the compliance and efficiency of QA operations. Other related duties as assigned. Qualification and Experience 能力与经验 Education/Qualifications  The candidate should have at least a Degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or a related discipline. Certification and trainings such as auditor training will be advantageous. Leadership Competencies Models Integrity Focus on value and customer Align for success Deliver results Learn for the future Job Required Competencies A minimum experience of 7 years in pharmaceutical or biotechnology in quality assurance, GMP compliance, operations or validation, ideally in a multinational company. Aseptic Filling experience is required and experience in the new DP facility project is expected. FDA/EU cGMP know-how and a thorough understanding of ICH guidelines, together with exposure to the international regulatory network. Able to logically solve problems in order to find timely solutions. An ability to interact and communicate with all types of personalities in an effective and diplomatic manner Good decision-making capability Experienced in new facility startup readiness and operation ramp up Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders     Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.

Other Ai Matches

Business Continuity Management & SHE Expert for PTD Basel (temporary for 2 years) Applicants are expected to have a solid experience in handling Job related tasks
Procurement Capability Lead Sourcing Applicants are expected to have a solid experience in handling Job related tasks
实习医药信息顾问 Applicants are expected to have a solid experience in handling Job related tasks
Medical Value Partner Applicants are expected to have a solid experience in handling Job related tasks
Alternant - Ventes à Distance diabète (f/m/d) Applicants are expected to have a solid experience in handling Job related tasks
区域市场实习生 Applicants are expected to have a solid experience in handling Job related tasks
Senior DevOps Mobile Engineer Applicants are expected to have a solid experience in handling Job related tasks
零售区域重点客户经理 - 抗感染治疗领域 - 济南 Applicants are expected to have a solid experience in handling Job related tasks
(Sr)Electricity Engineer Applicants are expected to have a solid experience in handling Job related tasks
Patient Journey Partner Nefrología-Reumatología y EERR (Zona Sur) Applicants are expected to have a solid experience in handling Job related tasks
Manager Software Development - RTD Applicants are expected to have a solid experience in handling Job related tasks
Scientist, Antibiotics Discovery Applicants are expected to have a solid experience in handling Antibiotics Discovery related tasks
零售区域重点客户经理 - 抗感染领域 - 成都/乌鲁木齐 Applicants are expected to have a solid experience in handling Job related tasks
副总监 - 医院战略合作 Applicants are expected to have a solid experience in handling Job related tasks
Procurement Manager - Clinical Laboratories Applicants are expected to have a solid experience in handling Job related tasks
Application Specialist Applicants are expected to have a solid experience in handling Job related tasks
Customer Partnering Manager (m/w/d) im Bereich Ophthalmologie - Koblenz-Trier Applicants are expected to have a solid experience in handling Job related tasks
Supply Planning Analyst Applicants are expected to have a solid experience in handling Job related tasks
Global Study Area Lead Applicants are expected to have a solid experience in handling Job related tasks
Field Service Engineer - Next Generation Sequencing (d/f/m) Applicants are expected to have a solid experience in handling Job related tasks
Packaging Operator 包装操作工 Applicants are expected to have a solid experience in handling Job related tasks
Leiter Produktionsbetrieb Operations1 / Betriebsleiter / Asset Lead (m/w/d) – Sterilfertigung & Strategic Operations Applicants are expected to have a solid experience in handling Job related tasks
LATAM Business Process Excellence (BPE) Intern Applicants are expected to have a solid experience in handling Job related tasks