*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 "oraapps" group. To unsubscribe from this group and stop receiving emails from it, send an email to oraapps+unsubscr...@googlegroups.com. To post to this group, send email to oraapps@googlegroups.com. Visit this group at https://groups.google.com/group/oraapps. For more options, visit https://groups.google.com/d/optout.
