Career in Software Regulatory & Quality Assurance
Headquartered in Boston, USA, ReliSource is a provider of Specialized Products & Services and have been operating in Bangladesh for more than a decade providing High-Tech solutions to its Clients. Since its inception in 2003 it has been continuously working in new and challenging areas for its Fortune 500 Clientele to deliver significantly high ROI. ReliSource provides Device / Embedded Engineering, Enterprise Application Development, Enterprise Mobility and Testing/QA & Validation Services in the areas of Healthcare, Pharmaceuticals, Logistics & Supply Chain, Insurance and Unattended Payment Systems. In addition to challenging high-tech works, we offer a friendly environment where fun and career developments go together. The ReliSource family members are particularly proud of its ‘Culture’ that bonds everyone together with history of practicing Values & Ethics that develops a professional environment of excellence. This has not only created a sustaining existence for the organization and its members but also created many leaders.
Post Name/ Position Title: Senior Technical Product Regulatory & QA Engineer
Company Name: Relisource
Number of job vacancies: N/A
Type of Jobs Nature: Full Time / Part-Time
Nature of Job category: Non-Government job
Job Level: Entry / Mid / Top Level
Job Application Posting Date: 27 September, 2016
Jobs Application Deadline: 30 October, 2016
Job description / Responsibilities:
- Assist in the development of Standard Operating Procedures (SOP)
- Act as a gatekeeper of the SOPs, Govt. Regulations and other compliances in validation and qualification of computerized systems
- Review and approve documentation and software updates through change controls
- Analyze formal test results in order to discover and report the discrepancies
- Actively participate in evaluation of regulatory compliance of document, product, process and other changes
- Participate in research of regulatory affairs and dissemination of regulatory information to concerned stakeholders
- Regularly communicate with overseas clients located in the US and EU
- Juggle between projects and tasks to offer regulatory assistance
- Bachelor’s in Computer Science or Computer Engineering from any reputed university
- MBA from any reputed university is very much desired
Experience Requirements: 2+ years in a Regulatory and/or Quality Assurance position in a Pharmaceutical or similar company
Additional Job Requirements:
- In depth understanding of validation and qualification of computerized systems in Healthcare industry
- Proficient understanding of 21 CFR Part 11, HIPAA and other relevant FDA regulations
- Experience in company audit is a plus
- Experience working in a GAMP5 compliance organization is a plus
- Strong problem solving and analytical ability.
- Able to work independently.
- Ability to quickly learn/understand Client’s computerized systems
- Excellent communication skill in English.
- Excellent Writing/Technical Writing Skills
- Must be a team player
Age limit for jobs: 35 Years
- Very Competitive Salary and Long Term Benefits with Excellent Career Opportunity in a Focused & Stable organization.
- Opportunity to work in various cutting edge technologies.
- Overseas Tour with Opportunity to work with Global Companies.
- Most importantly a friendly work environment with opportunity to learn from a number of highly skilled mentors.
Jobs Location: Dhaka
Gender: Both (Male & Female)
Jobs Source: Bdjobs
Office Address: N/A
Email Address: firstname.lastname@example.org
Website Address: N/A
If you believe you are the right candidate, then send your CV to email@example.com with the exact subject line “QACS-30102016” on by October 30, 2016 and resume without recent passport size photograph will be automatically discarded.
IMPORTANT: Resume attached without above subject line will not be processed.