GMP Compliance Manager Engineering (m/f)
Unbefristeter vertrag Vienna (Wien Stadt) Design / Civil engineering / Industrial engineering
Job description
Job Description
Assurance of compliance to cGMP within the assigned area of responsibility (especially of clean utilities, process equipment, HVAC)
Implementation of standardized / harmonized GMP-relevant engineering processes, implementation of best practice procedures and systems within the assigned area of responsibility
Establishment, review / approval of engineering-relevant building specific-, site- or system-SOPs, performance of gap assessments and establishment of CAPA-plans in order to facilitate the implementation of new / revised procedures
Representation of Engineering Compliance Management in engineering department meetings within BT / Aseptics as well as cross-functional engineering meetings with other business units
Expert / single point of contact for all GMP-related questions within the assigned area of responsibility
Assumption of the role as qualification coordinator within the assigned area of responsibility during expansion / improvement projects as well as review and approval of all qualification documents
Performance of Engineering checks, preparation of the corresponding report as well as follow-up regarding timely closure of CAPAs to observations within the assigned area of responsibility
Support of all engineering-units during audits and inspections; i.e. preparation, attendance, follow-up and Request Manager
Training of BT / Aseptics Engineering associates on current GMP standards and SOPs
Reporting of KPIs
Mutual representation of “Compliance Manager Engineering” in case of holidays, external trainings and meetings, etc.
Position Title
GMP Compliance Manager Engineering (m/f)
Desired profile
Minimum requirements
Key Performance Indicators:
Assurance of GMP-Compliance within the assigned area of responsibility
Quality of qualification / validation documentation
Quality of life cycle documents
Successful audits and inspections
Education:
Higher technical education in Engineering
Experience:
Work experience (2-3 years) as Plant Engineer or Project Engineer required
Experience concerning qualification / validation preferably
Language:
German - fluent in spoken and written
English - fluent in spoken and written
We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least €49.840, per year)
Job Type
Full Time
Country
Austria
Work Location
Schaftenau
Functional Area
Technical Operations
Division
Novartis Technical Operations
Business Unit
NTO ASEPTICS
Employment Type
Regular
Company/Legal Entity
Sandoz GmbH