Quality Assurance Manager

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 Initiat