Location: Yerevan, Armenia
Category: Information Technology
Type: Full Time
Deadline: 01-Nov-18 12:00:00 AM
Salary: N/A
Description
Title: Quality Assurance (QA) Specialist
NoyMed LLC is a contract research organization based in Armenia with rapidly growing global reach in the biotech industry.
We are looking for a Quality Assurance Specialist capable to excel at the nexus of fast-paced business environment and hard-shell regulations.
Responsibilities
-Key job responsibilities may include, but are not limited to:
-Develop, implement and revise policies, standard operating procedures, other quality controlled documents and business processes
-Ensure compliance to external requirements established by international organizations (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) and different government bodies (such as USA, US FDA, EU, EMA) as applicable
-Conduct research related to quality standards, regulatory requirements, best practices and other areas
-Make research results actionable and recommend practical solutions to current business needs
-Assist with computer system validation activities such as writing and reviewing requirement specifications (user requirements, functional requirements), system qualification protocols and test scenarios in compliance with applicable good practice guidelines and regulations
-Work closely with different subject matter experts and coordinate their inputs.
-Provide technical and writing assistance to QA department
-Assist QA department in all its operations such as conducting audits, hosting audits, conducting and reviewing different assessments and analysis, managing deviations and CAPAs, managing internal training, implementing and enforcing different managerial controls, etc.
-Manage documents and records, implement and operate necessary controls over documents and records
-Know and follow the quality controlled documents
-Carry out other administrative responsibilities related to quality assurance and quality control
-Perform other related duties as assigned by immediate supervisor(s)
RequiredQualifications
-Master's degree in Business Administration, Public Health or a related field
-Analytical mindset with ability to do research and solve problems
-Detail oriented, goal getter, self-starter and team player
-Strong sense of discipline and responsibility
-Efficient multitasking skills
-Capacity to prioritize and meet deadlines
-Commitment to providing high quality work
-Strong oral and excellent written communication skills in English
-Strong working knowledge of Microsoft Office, advanced Excel skills
-Knowledge of relational database systems is a plus
Benefits
Job URL: iJob.am - QA Specialist @ Noymed LLC
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