Swiss Garnier - Senior Manager/AGM - Quality Compliance (5-6 yrs)

Essential Duties & Responsibilities :

- Monitoring and verification of implementation of CAPA against market complaints, deviations, OOS/OOT and other QMS events

- Ensuring compliance of written procedures in routine working gap analysis, remediation and implementation of improved quality system to ensure the overall compliance.

- Spearheading source inspection activities, monitoring/revising quality documentation, maintaining compliance with standards pertaining to industry and reporting internal audit information.

- Guidance update and GAP assessments.

- Regulatory/external/Customer audit and Compliance verifications

- Preparation and review of Self - Inspection (Internal Audit) and inspection readiness planner and monitoring its execution

- Preparation and Review of critical SOP's and implementation the same

- Compliance Review of response to regulatory agency and track compliance to commitments made in the response

- Ensuring implementation of quality policies/ standard practice/ directives at site and verifying its compliance

- To impart training on GMP related and other technical topics and responsible for overall training activities of location as per site training SOP designated to meet cGMP standards of pharmaceuticals company

- Suggest area of improvement in product quality and GMP enhancements at the site and prepare suitable proposals

Experience Required:

- Skilled in performing cGMP/GxP gap assessment, remediation of manufacturing site and regulatory inspections as well as response preparation for inspectional observations.

- Skilled in preparing Specifications, STPs, Protocols, SOPs, Validation report, Qualifications and scientific reports to respond to regulatory deficiencies queries by scientific rationale & results

- Knowledge on the local/regional regulations

- Knowledge on Compliance Standards and Regulation as applicable to the market.

- Experience in shop floor-handling IPQA, Process and Technical knowledge, Operational Quality, QA/QC exposure and External / Contract manufacturing sites