*Good day Partners,*
*We have a contract Job opportunity with our Pharmaceutical Client in **Foster City, CA** for* *QA Engineer* *for duration of **6 to12 Months. * *If you are interested, Please revert back with your latest resume and contact details and expected pay rate to **msha...@tech-netinc.com* <msha...@tech-netinc.com>* (MKM Shahid)* *Role: **QA Engineer* *Location: **Foster City, CA* *Duration: 6 to12 Months* *Local to California candidates highly Preferred* *Minimum 8+ years experience with **Pharma client experience will be mandatory.* *Job Responsibilities: * The QA Document Coordinator will participate in cross-functional teams as a QA representative and coordinate resulting QA actions within the QA group. · Analyzes Change Requests (CRs) for completeness. · Collaborates with customers to ensure changes are concise and complete. · Assists with the correct and timely implementation of documentation to support filings, projects · Advanced knowledge of computer systems which support document control processes · Interacts with appropriate departments to establish project priorities and deadlines · Revises standard operating procedures (SOPs) and work instructions for continuous improvement of documentation systems. · Coordinates the distribution and maintenance for GXP documentation. · Provides support to internal and regulatory audits/inspections as required. · Performs administration of the Quality Management System in support of GXP documentation. · Supports the generation of monthly document control metrics. · Participates in the development of training materials. · Identifies areas for improvements, and proposes changes to management. · Performs advanced word processing tasks including providing support to customers with documentation issues. *Key Differentiating Contributions:* · This is an intermediate position where primary responsibilities include: processing documents following defined processes/procedures, recommending process improvements. · Understanding of systems used to support document processing, archival and knowledge management associated to Document Control. · Works on more complex, non-routine projects/assignments where analysis of situation or data requires a review of identifiable factors. · Exercises judgment within well-defined and established procedures and practices to determine appropriate action with minimal supervision. · Writes and revises standard operating procedures (SOPs) and work instructions for continuous improvement of documentation systems. · Coordinates the distribution and maintenance for GXP documentation. · Provides support to internal and regulatory audits/inspections as required. · Conducts on the job training and day-to-day guidance for document control staff and end users. *Knowledge & Skills:* · Demonstrates advanced understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, GxP, ICH, etc. · Demonstrates advanced working knowledge of Document Control fundamentals, knowledge of the process, effects, and the relationship between the document change process and products. · Demonstrates advanced working knowledge of Quality Systems fundamentals. · Demonstrates general working knowledge of Electronic Document Management Systems (EDMS). · Demonstrates advanced understanding of computer system administration. · Demonstrates good verbal, written, and interpersonal communication skills. · Demonstrates advanced knowledge in Microsoft Office applications. · 6+ years of relevant experience and a High School diploma. · 4+ years of relevant experience in the pharmaceutical industry and a BS. · 2+ years of relevant experience and a MS. *Thanks & Regards,* *Shahid MKM* Staffing Manager *Tech - Net Inc* Email: msha...@tech-netinc.com Direct: 916-673-3107 Board: 916.458.4390 EXT: 101 101 Parkshore Dr. Suite #100, Folsom, CA 95630 web: http://www.tech-netinc.com *A WMBE certified company* -- You received this message because you are subscribed to the Google Groups "Hot List" group. To unsubscribe from this group and stop receiving emails from it, send an email to directclienteq+unsubscr...@googlegroups.com. To post to this group, send email to directclienteq@googlegroups.com. Visit this group at https://groups.google.com/group/directclienteq. For more options, visit https://groups.google.com/d/optout.
