GMP Compliance Manager Engineering (m/f)

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