Prulab Pharma Ltd. is currently seeking an engaging and influential personality able to Drive and lead the Quality Assurance (QA) team (QA systems, validation and Quality Control) to achieve targets and aspects of the overall business vision.
*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.