*Kindly submit resume at [email protected]
Job Title:* QA Specialist in *Quality and Compliance* for Commercial
department of Pharma company
*Education: *BS/BA in Engineering/ Biology/Microbiology/ Chemistry/
Biochemistry/ Pharmacy
*Work Location:* Collegeville, PA / Madison, NJ / Groton, CT
*Relevant Experience (Yrs):* At-least 5 years experience in IT organization
with *2 years in Quality and Compliance*(*BTQ & C*) related activities in
the pharmaceutical or biotech industries supporting IT initiatives in the
commercial areas
*Technical/Functional Skills: *
1. Good understanding of Quality & Compliance in the commercial areas of
the IT department of any pharma or bio-tech company
2. Previous experience in Q&C activities for CRM applications
(implementation/upgrades)
3. Understanding of industry standard life-cycle activities
*Experience Required:*
1. Experience in working for industry standard life-cycle related
activities, compliance risk profiling etc
2. Experience in CRM domain and applications in the commercial areas
3. Ability to effectively work within Quality, and across network
channels, to accomplish goals
4. Working experience in Sales and Marketing applications
*Roles & Responsibilities:*
1. Working closely with the Business Line / Project Manager and Technical
Writers to complete the industry standard life-cycle Tailoring Form and
scale deliverables (as needed)
2. Reviewing industry standard life-cycle requirements documents and
ensuring compliance requirements are included wherever required
3. Ensuring the completion of all deliverables as agreed in the industry
standard life-cycle Tailoring Form and approving the appropriate
deliverables according to the required deliverable signature matrix
4. Initiating or reviewing Compliance Risk Profiling as part of the
Requirements phase of the project of High or Medium compliance risk
category
5. Authoring regulatory and process documentation as required
6. Working closely with project teams in remediating out all outstanding
compliance related issues & deviations before project closure, if
possible
7. Reviewing procedural records for projects and standard operationalized
processes
8. Ensuring the completion of training related to projects and guide
project teams (as needed)
9. Ensuring that Compliance Summary Report is written within stipulated
duration of project deployment (and maintained on a periodic basis in
support)
10. Reviewing Test cases and Traceability Matrix very closely ensuring
compliance requirements are tested ( if in scope)
11. Working with project teams and various records management / retention
teams to ensure that the project deliverables get approved and uploaded to
the correct folder in standard repository
*Generic Managerial Skills:*
1. Excellent client management skills
2. Working with multicultural, cross-functional work teams
3. Excellent oral and written communication skills
4. Advancing a quality culture in the work environment
*Thanks & Regards*
ATTY
Manager – Recruitment
IDC Technologies, Inc.,
1851 McCarthy Boulevard, Suite 116, Milpitas, CA, USA, 95035,
Contact #: 408-457-9399 Ext: 2026 || Email: [email protected] || Web:
www.idctechnologies.com
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