Supplier Quality Specialist
4 weeks ago
Responsibilities:
- Process all Change Plan/Requests for creation or changing of company's documents through the current Document Management System following applicable policies, process and procedures
- Perform proofreading of documents and approve submitted to the Documentation Area for further processing in Document Management System
- Identify and notify impact of submitted changes to existing procedures Management System or other quality system applications such as DCS, SAP, LIMS, MES In Document POMS, Delta V, Maximo, etc
- Notify Training area on the document revision/creation or obsoleting
- Assign correct and accurate Effective and Periodic Review Dates to QS documents and specifications
- Controlled Issuance of paper records (e.g. batch records, logbooks, SOPs) distributed to respective area for execution
- Ensure synchronization between multiple document changes and multiple company's sites Serve as a Trainer of the Document Management System and Good Documentation Practices to other employees
- Generate status reports to support the business and maintain documentation area metrics
- Receive and review global document changes and communicate to applicable SMEs
- Maintain, organize, scan and retain documentation in the defined area Responsible of Record Retention of Quality area documents Assure all controlled documents are retained according to company's Policies and procedures
Requirements:
- Minimum Diploma in Business Administration, Biology, Chemistry). Pharmacy. or Engineering
- Knowledge of quality compliance areas as well as regulations and standards affecting APIs and Biologics is desired but not required
- Minimum of 2+ years working on Documentation Control related areas in a Compliance (GxP) environment
- Ability to quickly know products and processes in order to assess quality issues Total commitment to quality and maintain a high standard of work at all times Demonstrates the highest levels of integrity and a strong work ethic.
- Good planning and scheduling skills
- Good communication skills both verbal and written
- Good interpersonal skills
Job Type: Contract
Contract length: 6 months
Tell employers what skills you haveMES
Document Management
DCS
Quality System
Interpersonal Skills
Administration
Chemistry
Biology
SAP
Compliance
Good Communication Skills
LIMS
Proofreading
Scheduling
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