Quality Management

Baris Consulting GmbH
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About Us

Sema Baris Sema Baris (Dr. sc. techn. ETH) has 15 years of experience as responsible person and Head QA in the pharmaceutical industry. She brings a wide range of expertise in GMP, GDP, GLP and GCP as well as CAPA management. As a qualified lead auditor, she has successfully carried out numerous audits in Switzerland and other European countries. Her close cooperation with health authorities has always yielded the desired results.

Halim Baris Halim Baris (Dr. sc. techn. ETH) with 30 years of experience in the industry has been involved in QM-Systems for Automotive since the first ISO/TS16949 in 1999 and looks now forward to support companies in the implementation of the new IATF16949 standard. Following his last function as Global QM Director in the semiconductor industry, Mr. Baris is now active as consultant.

quote

« The time for action is now.
It’s never too late to do something.»

– Antoine de Saint-Exupéry

dienstleistungen

Services

Baris Consulting: Your partner with a proven track record in industry.

Quality Assurance

Efficient, sustainable support in Audit Management & preparation / monitoring for Health Authorities Inspection, CAPA Management, Documentation, Risk Management, PQRs, Qualification / Validation, Deviation & Complaint Management. Interim QP/RP (FvP) according to Swissmedic Regulation (AMBV). Ensuring to fulfill all requirements according to GMP / GDP / GCP / GLP as interim / external Manager QS.

ISO and IATF Standards

Preparations (GAP analysis, definition and follow-up of actions) to important audits according to ISO9001, IATF16949, ISO14001 and specific customer audits. Establishment of management systems and creation/improvement of documentation based on these standards.

Process optimization and tools

Analysis of business processes and overseeing the implementation of defined actions; optimizations in local and global Quality Management; training of Q-Tools; introduction of Lean Management. Definition and implementation of a customized, efficient Lean Organization.

zitat-two

« Quality is not an act but a habit. »

referenzen

References

We have a combined 30+ years’ experience in the pharmaceutical and manufacturing industries. In the field of quality assurance and management, we have worked for the following companies: