Quality Assurance Manager
*Managing the overall quality of the product and Quality Management System (QMS) by making sure it is manufactured, tested and released to GMP standard.
*Provide overall positive expertise and timely direction of customer audits, CAPA’s, regulatory expectations and batch reviews.
*Plans audit calendars and leads GXP audits of CMOs, CROs, distributions centres and other service providers.
*Manage self-inspections , Internal quality audits and ensure its compliance.
*Review and approval of calibration /Qualification/Validation protocols, reports and ensure its execution.
*Oversee Quality management systems across the organization and carry out root cause and trend analysis (e.g. OOS/OOT, Deviation, PQR management, Change control),
*Keeping site in compliance for all time readiness for any regulatory audit.
*Prepare metric data related to support management review process.
*Post graduate degree or degree level in either a relevant scientific field (i.e pharmacy, chemistry, Pharmaceutical Management) with significant relevant quality management experience in a GMP compliant Pharmaceutical company.
*Experience working closely with the Quality Management System (QMS), leading a team and involved directly interacting with the regulatory authorities with respective to regulatory inspections is expected.
T*hose with experience in Lean / Six Sigma improvement methodologies will be desirable however not essential.
*Firm understanding of Quality Assurance activities /cGMP/cGLP and QMS procedures in a pharmaceutical manufacturing unit as well as in warehousing and distribution.
*Good knowledge on Pharmaceutical Microbiological activities is desired but not mandatory.
*Excellent understanding of European regulatory environment.
*Excellent organisational, coordination and presentation skills.
*Excellent verbal & written communication and interpersonal skills.
Prulab Pharma offers employees a comprehensive benefits package that includes competitive salaries, comprehensive medical, dental and vision benefits, paid time off and volunteer hours, education assistance and much more.