Job Title: QA Manager/ Sr. Manager
Company: Coral Drugs. Pvt. Ltd.
Workplace Type:Full - Time.
Job Location:Sonipat, Haryana.
Experience:10+ Years. (Experience within API manufacturing companies is preferred)
Company Description:
Coral Drugs is an integrated and independent, research based international pharmaceutical company that produces a diverse range of high-quality API's and is headquartered in Delhi NCR, India. Our API focus covers several therapeutic areas, and our facilities are approved by the US FDA, EU GMP, and Indian regulatory agencies. At Coral, we believe in maintaining excellent quality standards for our products, services, and quality systems.
Role Description:
Handling of Market Complaint followed by Investigation, Root Cause analysis and CAPA.
Annual Product Quality Review (APQR) preparation/review through manual/Software (Caliber a PQR).
Handling of regulatory inspection & Customer Audits and writing correspondence/responses.
Quality management System, Initiation/review of Change Control, Incident, Deviation, CAPA management and implementation through the eQMS software.
Monthly & yearly closing and profitability analysis and Monitory day to day Financial & Checking of all Accounting related work.
Annual report submission to regulatory FDA
Review of Process Validation, HVAC, Autoclave and Media Fill validation Reports.
Qualifications:
Bachelor's degree or master's degree in Pharma.
Interested candidates can share their resume at hrcdpl-4@coraldrugs.com or WhatsApp resume @8199986208
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