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Quality Assurance Manager
Eingestellt von Skillsearch Limited
Gesuchte Skills: Network, Engineering, Client
Projektbeschreibung
APR/PQR Specialist
You will be part of the Annual Product Review/Product Quality Review reporting team for all Pharma commercial products. The group incorporates approved annual APR/PQR reports from the entire supply chain including Contract Manufacturing Organisations, gathers input from global and network functions, coordinates cross-site and end-to-end reviews, analyzes for trends and issues to assess the overall state of control for the manufacturing process and product quality. When necessary, appropriate actions are developed collaboratively, documented and initiated.
Tasks to be supported:
- Author APR/PQR reports independently for products with complex supply chains.
- Quality Data collection in various Quality Systems and Databases
- Perform comprehensive assessment of product quality by analysing/evaluating end-to-end APR/PQR data to ensure state of control for manufacturing processes, specifications and control systems.
- Collaborate and communicate with all site APR/PQR business process managers, global/network functions and Quality Product Leaders to ensure timely and accurate APR/PQRs are provided and analyses lead to appropriate conclusions.
Candidate Profile:
- B.A, B.S. or higher degree (preferably in Life Science or Engineering) and at least 3 years of experience in the pharmaceutical or biopharmaceutical industry
- Work experience in Quality, Pharmaceutical Manufacturing or Process Development as well as local site and emerging markets experience are required
- Knowledge of product manufacturing processes (DP/Packaging) and quality processes and systems as well as knowledge of the regulatory environment
- Hands-on experience with Annual Product Review/Product Quality Review documents is preferred
- Excellent technical writing/editing skills including proficiency in MS Word, Excel, and PowerPoint. Experienced in generating and presenting complex data graphs and reports
- Demonstrated expertise in analytical data analysis and critical thinking skill
- Fluent verbal and written communication skills in English and in German required
- Demonstrated expertise in analytical data analysis and critical thinking skills
- Ability to manage and influence stakeholders to deliver supporting information on time is crucial to be successful in this role
In accordance with the Employment Agencies and Employment Businesses Regulations 2003, this position is advertised based upon Skillsearch Limited having first sought approval of its client to find candidates for this position. Skillsearch Limited acts as both an Employment Agency and Employment Business
You will be part of the Annual Product Review/Product Quality Review reporting team for all Pharma commercial products. The group incorporates approved annual APR/PQR reports from the entire supply chain including Contract Manufacturing Organisations, gathers input from global and network functions, coordinates cross-site and end-to-end reviews, analyzes for trends and issues to assess the overall state of control for the manufacturing process and product quality. When necessary, appropriate actions are developed collaboratively, documented and initiated.
Tasks to be supported:
- Author APR/PQR reports independently for products with complex supply chains.
- Quality Data collection in various Quality Systems and Databases
- Perform comprehensive assessment of product quality by analysing/evaluating end-to-end APR/PQR data to ensure state of control for manufacturing processes, specifications and control systems.
- Collaborate and communicate with all site APR/PQR business process managers, global/network functions and Quality Product Leaders to ensure timely and accurate APR/PQRs are provided and analyses lead to appropriate conclusions.
Candidate Profile:
- B.A, B.S. or higher degree (preferably in Life Science or Engineering) and at least 3 years of experience in the pharmaceutical or biopharmaceutical industry
- Work experience in Quality, Pharmaceutical Manufacturing or Process Development as well as local site and emerging markets experience are required
- Knowledge of product manufacturing processes (DP/Packaging) and quality processes and systems as well as knowledge of the regulatory environment
- Hands-on experience with Annual Product Review/Product Quality Review documents is preferred
- Excellent technical writing/editing skills including proficiency in MS Word, Excel, and PowerPoint. Experienced in generating and presenting complex data graphs and reports
- Demonstrated expertise in analytical data analysis and critical thinking skill
- Fluent verbal and written communication skills in English and in German required
- Demonstrated expertise in analytical data analysis and critical thinking skills
- Ability to manage and influence stakeholders to deliver supporting information on time is crucial to be successful in this role
In accordance with the Employment Agencies and Employment Businesses Regulations 2003, this position is advertised based upon Skillsearch Limited having first sought approval of its client to find candidates for this position. Skillsearch Limited acts as both an Employment Agency and Employment Business
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Ingenieurwesen/Technik