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Development Quality Assurance Manager, Pharmaceutical Company

Basel - BS - 4051

Development Quality Assurance Manager, Pharmaceutical Company

Dr. Reddy’s is an integrated pharmaceutical company, committed to provide affordable and innovative medicines for healthier lives. As a part of our global Generics organization, Dr Reddy’s Laboratories SA accelerates access to high quality generics in Europe true to our belief- Good Health Can’t Wait.
Location: Basel, Switzerland

This role will ensure the application of US FDA regulations including cGMP’s quality and compliance requirements applicable to US bound drug and combination device new product development, validation and launch for ANDA’s. The role will also be responsible for ensuring compliance within the EU and Swiss Medic regulatory framework.

Main tasks:
- Providing FDA regulatory interpretation, consulting, training and execution of QA activities in support of all design and development projects and assuring the design process (QbD and QSR) meets all requirements
- Manage continuous improvement consistent with established and evolving regulatory and company requirements for drug/device product development
- Execute supply base improvement strategies in coordination with the Director in US
- Support the development of supplier selection, qualification, improvement and monitoring framework and procedures.
- Drive supplier performance on quality, delivery, and conduct supplier Audits as required.
- Point-of-contact to the external vendors, quality support and interaction with key partners to maintain a close working relationship and oversight of our suppliers/ CROs.
- Quality System support: maintain vendor file, complaint investigations, vendor performance statistics
- Facilitate and conduct Risk assessment for products and continuously monitoring the residual risk and mitigation plan throughout the lifecycle of product.
- Quality oversight for products as it is related to QbD, Development, Exhibit batch, process validation including but not limited to, qualification, stability and control process in the development, design and launch of drug product and drug device combination products.

Requirements profile:

Technical skills:
- In-depth understanding of compliance to 21 CFR part 820(device and drug device combination products), 21CFR part 210 and 211 and CFR part 11 regulations.
- Skill set for assessment of device and drug device combination products , including review of formulation and analytical method validation documents, application of statistical tools like regression analysis, Statistical Quality Control( SQC) etc., DOE (Design of Experiment) during the product development lifecycle, Risk assessment and Process Validation (Product Performance qualification). - Knowledge of applicable regulations and directives, GMP/GDP, Quality Management Systems (QSR), technical understanding in pharmaceutical processes and equipment
- Good knowledge in MS Office and possibly SAP
- Fluent in English.

Education and experience:
MS in pharmaceutical science, chemistry, biology and/or engineering
Minimum of 10 years of experience out of which at least 3- 5 years of experience in Quality systems in pharmaceutical R&D is required.

Personal skills:
• Working in a self-responsible manner, excellent organizational abilities
• Attention to detail, reliable and trustworthy,
• Strong and effective communication skills, influencing and negotiation skills
• Excellent ability to build and maintain effective working relationships across departments and hierarchical levels, in a multi-cultural and multi-lingual environment.
Visit : 17
Stellenangebot Details
Arbeitsort 4051 Basel
Fachbereiche Beratung, BildungChemie, PharmaGesundheits-, SozialwesenInformatik, Computer, TelcoPräzisions-, HochtechnologienChemie, PharmaGesundheits-, Sozialwesen
Organisationsbereiche Prüfung, Qualitätssicherung
Funktionen Führungsfunktion
Arbeitspensum 100%
Stellenantritt 27.11.2018
Dr. Reddy`s Laboratories SA

Basel HR
Elisabethenanlage 11
4051 Basel


Basel HR

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