Senior Manager, Quality Assurance at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

06 Jul, 26

Salary

0.0

Posted On

07 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, Validation Guidelines, Validation Master Plan, Process Validation, Cleaning Validation, Equipment Qualification, Environmental Monitoring, HVAC Qualification, Audit Readiness, Deviation Management, Change Management, In-Process Checks, Batch Record Review, Risk Assessment, Quality Management, Vendor Qualification

Industry

Pharmaceutical Manufacturing

Description

* Proactively assess quality issues and ensure compliance to QA/QC as per regulatory requirements in manufacturing operations and quality function at site by keeping track of quality metrics. * Ensure all time readiness of site for regulatory/statutory inspections/ internal audits and Regularly monitor performance of each individual in Quality department. * Facilitate internal and regulatory agency audits, and ensure findings from site audits are understood, assessed and addressed in a comprehensive manner . Ensure closure of audit observations by reviewing the CAPA and driving its implementation. * Ensure implementation of requisite changes at the plant level as per global/local regulations. To escalate any Batch failure, Quality complaint, recall, critical observation etc. to senior management. * Provide leadership and direction to ensure achievement of accountabilities for all Quality sub functions at site. * Ensure timely updation and approval of all master documents i.e. BMR, SOPs, Specifications, site master file, validation master plan, schedules etc. * To ensure that validation system remain updated as per regulatory requirements and industry standards. Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities. * Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities. * Responsible for preparation of Standard Operating Procedures of Quality Assurance Department Responsible for preparation, review and execution of risk assessment activity related to Equipment / Process / Facility / System. * Responsible for review of media fill BMR. * To ensure timely release of manufactured batches by reviewing BMR/ BPR and their compliance. * To ensure In- process testing & release timely. * Training and post training evaluation of staff and worker: Identifying training needs, scheduling and conducting training program, training and qualification of trainer, certification and evaluation. Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance. * Responsible for review and approval of documents like Validation protocols, reports, QRM, SOPs etc. * Responsible for the assessment, review and Approval of Change Control, Deviation, CAPA, Investigation etc. * Responsible for approval of URS, DQ and vendor/ suppliers documents related to qualification. * Annual Product Quality Review (APQR/APR) Review: Review & trending of quality parameter to quality performance consistency. * Handling of Market Complaint: Complaint Investigation, root cause analysis, Impact assessment and risk assessment of received market complaint, FAR and Quality Defect reporting to Regulatory agency, trending of complaint and excellence study of complaint nature. * Recall and Product Failure Investigation: Product failure investigation, Periodic inspection of retained, controlled and stability sample, handle the mock recall and product recall. * To be part of investigation team & to perform the investigation of non-conformance (i.e. deviation, market complaint, OOS, OOT etc.). * Trend analysis of deviations to evaluate recurring problem and to recommend the CAPA if required. Self-inspection of the different departments. Preparation and review of self-inspection report. * To review the compliance/action plan against the noted observations noted during self-inspection. * Co-ordination and participation in Quality management review. * Approval of Master Documents like specification, Method of Analysis, Stability Study report, SOP etc. * Vendor Qualification: Handling the Vendor Qualification and Re-approval audit for RM (Raw Material), PPM (Primary Packaging Material), SPM (Secondary Packaging Material), Contract analysis laboratory and Contract services. Skills: * Regulatory Compliance & Validation Guidelines Knowledge - Expert * Validation Master Plan Development & Execution - Expert * Process Validation - Expert * Cleaning Validation - Expert * Equipment Qualification (DQ, IQ, OQ, PQ) - Expert * Environmental Monitoring & HVAC Qualification - Expert * Regulatory Inspections & Audit Readiness for Validation - Expert * Deviation Management - Expert * Change Management - Mastery * In-Process Checks & Monitoring - Mastery * Batch Record Review - Mastery

Responsibilities

The Senior Manager will oversee quality assurance operations, ensuring compliance with regulatory requirements and managing site audits. They are responsible for leading quality sub-functions, managing validation activities, and ensuring the timely release of manufactured batches.