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Ashkom
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Quality Compliance Support

Quality Compliance Support

Ashkom

2 - 3 years

0 - 1 Lacs

Sanand

Posted:2 months ago| Platform:

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Skills Required

E-learning Capa Quality Compliance SOPs eQMS Compliance Vendor complaints Good Documentation Practices Powerpoint MS Tools Gdp Excel Quality Compliance support Investigation CGMP

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities Maintain site Annual validation Plan & track activities as per Validation Plan. Tracking & follow-up on Validation & Change Control records at site. Coordinate for eQMS records (Investigation, CAPA, effectiveness checks) closure at site. Monthly trending of Non-Conformance records at site. Data update for Daily & Monthly Quality meetings. Govern Global SOPs compliance at site. Manage periodic review of documents (SOPs, attachments, forms etc) at site. Vendor complaints: Handle vendor complaints at site for getting actions closed at site & with suppliers for on time closure. Training: Ensuring completion of site trainings as per training calendar at site. Work with Site "Education & Training Lead" to improve site training program (e-Learning). Key competencies Skill Required/ Tools/ Software: The individual is responsible to work in compliant with Good Documentation Practice (GDP) and current Good Manufacturing Practice (cGMP). Interpersonal Skill: The individual must have good communication skill with team, team-work capabilities, patience to work under pressure. Digital Skills: Effectively use MS tools, i.e., Word, Excel, PowerPoint, in day-to-day operations. If required, need to operate company software

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Quality Compliance Support