Boehringer Ingelheim is a research-driven pharmaceutical company and one of the top 20 pharmaceutical firms worldwide. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally in over 100 countries and has more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine. In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 23.1% of its net sales.
Post : Manager - QCO
Job Description:
Compliance with all regulatory requirements such as GMP and GDP is a critical success factor for commercial product supply to our customers. The Head of Commercial Quality in the BOPU is responsible for the implementation and maintenance of a regional quality management system for GMP/GDP as well as all health regulated activities (covering Human Pharma and Animal Health requirements) ensuring that all relevant external (e.g. GMP, GDP) and internal requirements (e.g. BI Policies and Procedures) are implemented, monitored for performance and adherence, and improved, if required. Responsible for the successful conduct of authority inspections. Head of Commercial Quality in the BOPU makes final decision on strategic GDP/GMP relevant questions in alignment with the management team.
Responsibilities:
- Management: responsible management of the Commercial Quality unit in line with BI’s corporate strategy on the basis of the principles, targets and strategies of the Business Centres (HP and AH) and on the basis of the approved budget.Ensure that necessary interfaces to other departments (e.g. SCM, Infrastructure, IT, Compliance, Law, Sales) are established and maintained. Cooperate, communicate with, and provide information to other organizational units.Manage authority inspections (GDP and GMP) in the OPU. Represent quality function in projects with GDP/GMP relevance
- Strategy, Planning and Monitoring-1)Budget responsibility for the quality cost centers on BOPU level 2)responsibility for budget realization and ongoing monitoring.3) drive the implementation status / maintenance of the QMS. 4)Responsible for QMR (Quality Management Review)
- Leadership- disciplinary management of quality unit employees,conduct employee reviews,make suggestions about personnel matters with regard to requirements, qualifications and placement, initiate training measures for employees,ensure completion of the necessary GxP training sessions,decide about holiday leave and other absenteeism besides business travel of the quality unit employees
- Within the quality unit, accountable for fulfilling the following roles:,LAC Chair,LPCO,GDP responsible person,Technical director,Chair for Quality management review board,Responsible for training related to Quality of the team.,Implementing/ revising relevant GMP / GDP quality systems related to commercial product supply to meet the continual needs of BI and the local authorities and ensure that products and processes/systems are delivered to the customers with a consistent high quality standard and in accordance with BI requirements and the local legislations.
- Responsible for successful development, implementation, and maintenance of a regional quality management system covering internal (BI) and external (laws, guidelines) requirements.
- Establish and maintain a Quality Manual that describes the QMS of the BOPU. Align with other key functions in the BOPU for continuous improvement of the QMS.
- Accountable for the implementation and development of the local Quality Management System (QMS) covering GMP/GDP aspects as well as health regulated acitivites on BOPU level,Ensure continuous improvement of processes and working steps along the responsible process chain and interfaces
Candidate Profile
• MSC/Preferred graduate in pharmacy Relevant qualification in Quality Management at level 5 or above or demonstrable relevant experience...
• Qualified to a minimum of lead auditor level in a relevant.Thorough knowledge of GMP / quality regulations and compliance regulations with practical expertise in QC/QA/Manufacturing in pharmaceutical /vaccine industry
Additional Information
Qualification : M.Sc, M.Pharm
Location : India
Industry Type : Pharma
Functional Area : QCO
End Date : 25th August, 2018
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