Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Piramal Pharma Limited
Designation : Manager
Reporting To : Lead – Technical Support
Function : Quality Assurance
Functional Area : Quality Systems Support
Job Role Summary : GMP compliance at PPL sites. Ensure implementation/remediation of the Quality systems, procedures and practices at the identified site(s) as per current regulations and organization expectations. To implement Corporate initiatives.
Job Profile :
  • On-site/ virtual support to quality systems, compliance and remediation activities at manufacturing sites.
  • Effectively track actions identified for restoring compliance at identified sites. Resolve the red flags and raise alerts timely.
  • Generate risk papers, support investigations and mitigation plans for business sustenance and continuity.
  • Keep abreast of changes to quality regulations and guidelines; generate the action plan and verify the compliance for patient safety, regulatory compliance, product quality and business implications.
  • Responsible for following the safety and environmental procedures deployed at the Kurla office and sites.
  • Corporate Initiatives: Execution of assigned corporate initiatives.
Job Requirements :
  • Expertise in Quality Assurance with experience in Formulations and API
  • Sound exposure of QMS applications with experience of minimum 12 years in reputed Pharma companies
  • Experience in QA and manufacturing operations.
  • Worked in regulatory approved facility; experience of facing regulatory inspections.
  • Strong verbal and written English communication skills.
  • International exposure and a candidate with a US Visa preferred.
Work / Job Experience : 12 Years
Type of Experience : Regulated Pharma Quality assurance, Quality Applications, Manufacturing experience
Academic Qualifications :

Post-Graduate in Science/ B. Pharm/ M. Pharm or relevant technical qualification

Website Linkedin Piramal Pharma Limited

To apply for this job please visit piramalpharma.wd102.myworkdayjobs.com.