quality engineer - Bengaluru, India - BPE Biotree India Pvt.

Description

ZETA – BIOTREE is a leading supplier of Pharmaceutical Machinery to the Biopharma industry and includes companies In India and Globally.

ZETA -BIOTREE has established itself as a reliable and globally active engineering partner. ZETA designs, builds, automates and qualifies equipment for aseptic liquid production processes in the biotech and pharmaceutical industries. Biopharmaceutical agents such as anticancer agents, insulin, vaccines, infusions and the like are produced on these highly complex "tailor-made" plants.

ZETA – BIPOTREE is in the process of setting up an Engineering center at Bangalore, to support the group globally.

We invite applications for the following positions.

General:

Contribute to the development, implementation, evolution of standards in the department of the company.

Supporting the (Corporate) Head of Executive Quality in the department of standards (QM documents)

Identify causes of errors and develop optimization measures in cooperation with EQ Engineer / Manager L2

Level 1: Executive Quality Engineer

Review of quality assurance, qualification requirements from contract documents (QA/QF).

Comparison of customer requirements with regulations (norms, guidelines, standards etc).

Establish quality specifications and documentation requirements for the project planning and creation of QF documents (QRA, TRM, TDM, QMP and TS).

Carry out the quality related activities in the project in coordination with the project staff.

Project specific training in the project team.

Set milestones in the schedule regarding EQ (SW FAT, FAT and SAT dates), if necessary, in cooperation with the EQ CTM/PL.

Coordinate time plan/hand over quality information for vessel FATs and package unit FATs with LE FAT team.

Preparing and issuing test protocols and test documents to project members who carry out quality – relevant tests.

Coordination, organization and monitoring of tests (Electr, SW, mech, fuct, HVAC, clean room, documentation).

Test Verification: Checking for compliance with the agreed test execution (type and scope) and checking the tests for traceability.

Monitoring the storage of digitized test protocols relevant to project quality in the project folder.

Monitoring/supervision of the open issue list.

First activities as core team members (CTM, see Level 2) for EQ in a project (with support of a mentor if needed)