Experienced Supplier Qualification Management Specialist (SQM Specialist) for supplier of Sartorius BPS globally. SQM Specialist will work to ensure Sartorius suppliers, maintain a compliant quality system by abiding by Sartorius internal requirements as well as ISO/GMP requirements.
The Quality Supplier Professional will be responsible for qualifiing suppliers and verifying quality standards in accordance with the requirements of Sartorius. The holder of this position serves as the liaison for suppliers and is in charge of performing regular supplier audits to ensure compliance with regulatory standards, as well as actively participating in strategic development based on quality control plans.
Main Responsibilities & Tasks:
Responsibility for defined Supplier
Responsible for qualify or disqualify suppliers, together with other involved departments (e.g. Sourcing)
Contact person for site quality departments
Responsible for Qualification of Suppliers from Sartorius BPS from a quality perspective
Responsible for the execution of supplier audit
Responsible for the audit planning, execution, preparation/issuance of audit reports and closure of audit observations.
Identify and conduct follow-up reviews to implement and validate corrective action plans.
Maintain files generated from each audit.
Responsible for timely issuance of audit reports and closure of audit observations.
Responsible for Supplier Quality Assurance Agreements (SQAA)
Investigation where a SQAA is mandatory
Creation of a draft version
Communication to the Supplier
Negotiation with the supplier
Signature and release of the SQAA, together with the involved department
Update global electronic data management system with all pertinent supplier information.
Prepare quality metrics and compile summaries to effectively communicate status and recommendations to Quality Management.
Effectively work with suppliers to improve processes and procedures related to quality.
Qualifications & Skills:
Bachelor's degree in a relevant engineering subject or long term experience in related fields
5+ years' experience in a Supplier Quality capacity ideally within the biomedical or pharmaceutical industry
Certified Quality Auditor to ISO/GMP standards
In depth knowledge of Quality auditing, and regulatory standards
Good Technical Engineering knowledge, including ability to understand engineering drawing and standards
Ability to develop realistic work plans, set personal goals that align with company goals
Well-organized and methodical, with a superb attention to detail
Ability to prioritize and manage daily assignments
Excellent written and verbal communications skills to represent the company professionally
Establish and maintain positive working relationships with all inand external interfaces
Fluent in English
Interested? Driving our future growth requires talented people. Sartorius is a dynamic organisation suited to people who want to showcase skills, be recognised for expertise and thrive in a vibrant and innovative environment.
To find out more about Sartorius as an employer visit us on Sartorius Careers
Become part of our global team.
Reference Number
R832
Job Begin
March 01, 2020
Employment Mode
Full time
Position
Regular
Functional Area
Quality
Location
Yauco
(
Puerto Rico
)
