*Hi All* *I have an urgent requirement of *QA Specialist in Quality and Compliance for Commercial department of Pharma Company* at *Collegeville, PA*, Please send me resume at deepa...@idctechnologies.com* **
* * * * *Job Title:* QA Specialist in Quality and Compliance for Commercial department of Pharma Company *Work Location:* Collegeville, PA *Duration:* 6+ Months *Relevant Experience (Yrs):* 8 – 10 Years over all experience *Technical/Functional Skills * • Manage relation with key Clients • Participate on Commercial Quality projects and compliance initiatives representing Q&C. • Provide Quality Assurance Services to the commercial colleagues regarding regulatory compliance for projects and ongoing service delivery • Approve deliverables based on ELC or relevant risk based processes • Work with compliance and Commercial Q & C teams to identify compliance gaps, conduct risk assessments and define and implement remediation plans • Apply relative approaches and methodologies to successful Quality & Compliance (Q&C) project completion. • Support the analysis of quality data for Commercial Q & C operations in order to identify and lead targeted continuous improvement efforts to improve operational process effectiveness. • Participates in routine reporting on the state of compliance within Commercial Q & C functions • Support Commercial Q & C in achieving measurable compliance improvements in their business line operations. • Identify and work with internal Q&C operations and the Commercial organization to implement KPIs, metrics and standard reports used to identify service improvement opportunities. • Assure audit awareness & preparedness of operations and provide coaching / guidance as a compliance expert • Participate in, conduct and design functional specific assessments, based on standard Q&C governance, to ensure adherence to processes and controls • Partner with compliance and Commercial service areas so that high quality IT solutions are developed and deployed to meet customer needs, while adhering to applicable regulatory and Pfizer requirements • Continues to advance and develop knowledge in relevant Q&C subject area(s) and expands breadth of knowledge in related areas. • Often works on or initiates Q&C projects that are highly complex and require compliance risk management skills • Expected to independently develop Q&C project proposals • Capable of supporting multiple compliance related projects and initiatives simultaneously • Limited supervision required in day-to-day activities *Roles & Responsibilities * • Excellent customer relationship management skills • Excellent oral and written communication skills • Expert in principles, theories and concepts of pharmaceutical regulations; including industry knowledge of implementing controls within processes and tools. • Excellent in-depth understanding and working experience with compliance guidelines and regulations such as SOX, FDA and the Pfizer Common Requirements Set etc. • At least 2 years experience in SOX, GXP Compliance • At least 2 years experience in Information Technology • At least 2 years experience in the pharmaceutical or biotech industries supporting IT initiatives • Experience in MA 201 and PCI regulations • Demonstrated skills for independently guiding quality and compliance activities during system development and implementation. • Operational experience with having supported or led audits and having developed/managed audit remediation plans • Bachelors degree or higher • Demonstrated ability to communicate and negotiate with individuals and groups at multiple levels across the organization • Ability to work independently, manage multiple priorities, and work in an unstructured environment • Experience managing activities within medium to large scale, global IT projects Regards *Deepak* Sr. Technical Recruiter IDC Technologies, Inc, Milpitas, CA www.idctechnologies.com 408-457-9399 ext 2052 deepa...@idctechnologies.com dmstaffing (G Talk), dmstaffing31 (YM) "Under Bill s. 1618 Title III passed by the 105th U.S. Congress this mail cannot be considered spam as long as we include a way to be removed from our mailing list. Simply send us an e-mail with *REMOVE* as the subject line -- You received this message because you are subscribed to the Google Groups "Oracle Developers" group. To post to this group, send email to oradev@googlegroups.com. To unsubscribe from this group, send email to oradev+unsubscr...@googlegroups.com. For more options, visit this group at http://groups.google.com/group/oradev?hl=en.
