Manager - Quality Assurance - B.pharma (3-6 Yrs) Mumbai/atgaon/thane (qa/qc & Regulatory Affairs)

3 weeks ago

Navi Mumbai, Maharashtra, India Team Management Services Full time

Greetings from Team Management Services TMS an end-to-end HR consulting firm Currently we have an urgent job opening for the position of Quality Assurance Manager with one of our clients located in Atgoan Location Company Profile Our client began in April 2002 from Operations in Mumbai India with a diverse portfolio of pharmaceutical and healthcare products catering to global markets With a clear plan to establish a state-of-the-art manufacturing facility the company operationalized its first fully integrated manufacturing unit in 2008 complete with an R D center and a GMP-compliant warehouse The organization achieved its first milestone accreditation WHO-GMP India in September 2009 In 2006 the company expanded internationally by establishing its first overseas headquarters in the heart of Moscow Russia further strengthening its global presence Today the organization is dedicated to excellence in manufacturing research and the delivery of high-quality healthcare products worldwide Position Title Quality Assurance Manager Qualification B Pharma or related field Experience 3-6 Years Location Atgoan Job Responsibilities - Effectively interact with production and development teams to maintain product supply - Will coordinate tech transfer activities i e new product introduction writing technical and management systems report - Formulate new comprehensive quality systems - Participate in investigations trouble shooting - Co-ordinate with QA QC managers of manufacturing site in case of investigations - Will carry out vendor audits Third party manufacturer audits and internal GMP audits Required Skill Set - Strong experience with regulatory audits including USFDA EU MHRA TGA ANVISA etc Must have participated in or led these audits directly - Comprehensive understanding of QA and QC functions including QC stability validation qualification IPQA quality management systems compliance commercial releases and vendor audits - 3-6 years of experience at the QA Head or Compliance Head level in a reputable company or at the Quality Auditor level - Experience working with or managing third-party manufacturing - Excellent communication leadership and team management abilities Preferred Skill Set - Quality Assurance Quality Management - OOS Out of Specification OOT Out of Trend - QA Validation Auditing - Audit Compliance Change Control - Technology Transfer Contract Manufacturing - Cost-Saving Initiatives - Quality Support Troubleshooting If you have any questions or concerns please do not hesitate to contact us Also feel free to forward this email to your friends and colleagues if they are interested in this position Thank you and hope to talk to you soon in more detail ref biojoby com

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