北京招聘

Role:
Deploy the vision and the strategy for Compliance Audit throughout the supply chain. This includes audit and compliance for manufacturing and distribution activities within Roche,of contract organisations and licensees. This applies to manufacture of IMP (phase 2 and 3), API (biologics and small molecules), drug product as well as packaging and distribution of finished product and other GMP relevant operations.

Main responsibilities:
1. Auditing
·Establishes, lead and follow-up robust GMP Compliance Audits
·Reviews business processes and management practices to detect and prevent compliance and quality issues.
·Detects quality issues, global quality system gaps and ensure appropriate escalation and risk mitigation activities.
·Coordinates with PTD, PTQ departments and quality units of PT manufacturing sites to ensure Inspection Readiness by performing Mock Inspections and GMP awareness training.
·Provides expert review and audit in due diligence activities in the region to support Roche business initiatives.
2.GMP Training
·Supports PTQG team to develop, implement and execute a training program to qualify and certify auditors.
·Provides training on the job to new auditors when leading an GMP compliance audit
·Provides training on Roche’s quality standards and new regulations upon request.
3.General Tasks
·Is the expert and owner for Compliance GMP topics working closely with colleagues to ensure alignment across the Roche network.
·Is responsible to actively ensure the improvement of GMP compliance standards to ensure our right to operate.
·Takes an active role to improve regulations for the quality of our products to benefit our patients.
·Supports global projects according to PT needs.
·Supports the development of global quality standards by writing or reviewing Quality Requirements or Global Standards and processes within the Roche Pharmaceutical Quality Sysytem (PQS).
4.Surveillance
·Represents the company approach for compliance audit and systems improvements outside the company to initiate change for the industry.
·Participates in meetings and information gathering activities to ensure that Roche remains current in evolving regulatory expectations and industry trends.
·Supports PTQG’s GMP surveillance and external relations process.

MAIN CONTACTS AND RELATIONS
INTERNAL RELATIONS
Within Headquarters, providing appropriate service to all relevant departments ensures proper information exchange.
Specific contacts are defined as:
· Head PTQG
· Head of Compliance Audit A-APAC
· Head Compliance Audit APAC
· Manufacturing and quality functions of PT Operational Units
· PTQS team
· PTDQ team
· PTQP team incl. EU-QP (Supply chain Product management teams)
· PTP team
EXTERNAL RELATIONS
· Suppliers of API
· Contract Manufacturing Organizations (CMO)
· Licencees
· Roche affiliates including:
- Qualified Persons
- Quality Managers
- Local Regulatory Managers
- General Managers
· Chugai Quality Unit
· Experts / Consultants

Qualifications:
University degree in Pharmacy/Biology/Chemistry/Engineering/Biochemistry and demonstrated ability and experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience.
Must have experience of Pharma production processes, Quality assurance and product release, laboratory test methods and analytics (QC), validation processes in one or more manufacturing areas i.e. small molecule API, Biotech and biologicals drug substance, parenteral/sterile drug product, solid dosage forms.
Sound knowledge of Pharma GMPs, Medical Device regulations, ISO standards and international standards
Proven negotiation skills and the ability to influence lead people without having supervising function
Ability to interpret and relate quality standards as they related to Roche, CMOs and suppliers
Ability to make sound quality and manufacturing decisions with an E2E approach
Ability to build relationships cross functional and with outside companies
Project management experience and the ability to lead complex project
Knowledge of OE tools; i.e. statistical methods, FMEA, Six Sigma, Lean
Ability to travel approximately and up to 50% of the time

上海罗氏制药有限公司成立于1994年，是抗肿瘤、抗病毒、移植等关键领域的市场领导者。在大型跨国药企中，我们率先在中国建成了包括研究、开发、生产、营销等环节在内的完整的医药价值产业链。罗氏中国正向着成为罗氏全球第三个战略中心的目标迈进，以实际行动践行在中国长期发展的承诺。

我们始终以患者为中心，致力于帮助患者从根本上延长生命和改善生活质量。目前，罗氏在华拥有16个产品，覆盖8个治疗领域。我们与政府、医疗机构以及非政府组织等社会各界多方携手，共同探索创新的合作模式，通过一系列有影响力和可持续的举措惠及更多的中国患者。

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