Quality Manager/ Qualified Person (m/w/d) at xing
berlin, Berlin, Germany -
Full Time


Start Date

Immediate

Expiry Date

23 Dec, 26

Salary

60000.0

Posted On

24 Sep, 26

Experience

4 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Industry

Pharmaceutical Manufacturing

Description

Your tasks include:

Quality Manager:

  • Maintenance, design and further development of a comprehensive quality system as a basis for the European LUPIN Group activities (LUPIN Europe) and also at the local level at HORMOSAN
  • Monitoring and ensuring GxP compliance of the two local companies, as well as communicating GxP-related issues requiring approval to the relevant local supervisory authorities.
  • This includes the involvement of local, regional, and global colleagues, especially Indian colleagues.
  • Evaluation and qualification of suppliers, conducting supplier audits in the area of ​​product manufacturing and testing, within the EU but also partly intercontinental, specifically also in India
  • Creation, negotiation, implementation and review of quality assurance agreements with suppliers and partners
  • Project-related collaboration or project management for local or regional projects in the field of quality management

Qualified Person:

  • Batch releases as a qualified person / QP
  • Assistance with the preparation, follow-up, and support of official audits
  • Participation in and evaluation of deviations and product complaints, CAPA and change control processes
  • Contact person for business partners and authorities


How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities

Your tasks include:

Quality Manager:

  • Maintenance, design and further development of a comprehensive quality system as a basis for the European LUPIN Group activities (LUPIN Europe) and also at the local level at HORMOSAN
  • Monitoring and ensuring GxP compliance of the two local companies, as well as communicating GxP-related issues requiring approval to the relevant local supervisory authorities.
  • This includes the involvement of local, regional, and global colleagues, especially Indian colleagues.
  • Evaluation and qualification of suppliers, conducting supplier audits in the area of ​​product manufacturing and testing, within the EU but also partly intercontinental, specifically also in India
  • Creation, negotiation, implementation and review of quality assurance agreements with suppliers and partners
  • Project-related collaboration or project management for local or regional projects in the field of quality management

Qualified Person:

  • Batch releases as a qualified person / QP
  • Assistance with the preparation, follow-up, and support of official audits
  • Participation in and evaluation of deviations and product complaints, CAPA and change control processes
  • Contact person for business partners and authorities


Loading...