QA Manager Job Vacancies in Dombivli

Quality Oversight & ApprovalApprove analytical results, reports, protocols, methods, specifications, and other quality-related documents.Ensure the integrity, accuracy, and regulatory compliance of analytical and laboratory data.Provide final quality approval for services and deliverables provided to clients.2. Quality Management System (QMS)Establish, maintain, and continuously improve the Quality Management System (QMS) in compliance with GMP, GLP, and applicable regulatory guidelines.Ensure effective management of SOPs, deviations, CAPAs, change controls, OOS/OOT investigations, complaints, and risk management activities.Ensure data integrity compliance in line with ALCOA+ principles across all systems and documentation.3. Regulatory ComplianceEnsure compliance with applicable global regulations and guidelines, including FDA, EMA, ICH, WHO, and ISO standards.Lead, support, and manage regulatory inspections, client audits, and third-party audits.Act as the primary quality point of contact for regulatory authorities, auditors, and customers.4. Systems & ValidationReview and approve validation activities including analytical method validation, equipment qualification (IQ/OQ/PQ), computer system validation (CSV), and process validation.Ensure laboratory instruments, electronic systems, and software meet regulatory and data integrity requirements.5. Training & Quality CultureEnsure appropriate training of personnel on GMP, GLP, SOPs, and quality best practices.Promote and sustain a strong quality culture and compliance mindset across the organization.6. Risk Management & Continuous ImprovementIdentify potential quality and compliance risks and implement effective mitigation strategies.Drive continuous improvement initiatives to enhance regulatory compliance, operational efficiency, and service quality.

Designation :- Assistant Manager Quality Assurance Qualifications:- BScExperience:- Min 12 Years Of Relevant Experience In API Industry Salary:- As Per InterviewGender:- MaleJob Location:- Boisar, Maharashtra Industry:- Manufacturing Company

Job title QA Mgr.Department name Quality AssuranceExperience 12 To 15yrsIndustry Engineering services Reporting To PartnerReporter All QA /QC in place TeamSalary Range 7L To 7.2L/-PABased at Taloja, Navi Mumbai.Goals 1. Quality Management System review within 60days.2. Establish successfully a system for CAPA within 60days.3. Implementation of 5s in 24 zonal areas within the company in 90days.4. Develop and plan for presentation to management and drive the TQM best practices within the organization.5. Establish and Set Quality Objective according to departments.6. Establish and set KPI, KRA to achieve 8 departments quality and productivity.7. Identifying bottlenecks in Blasting, Machining department and streamline procedures. 8. Collecting and analyzing data to identify trends, detect variations, and make data-driven decisions through SPC in minimum of 2 departments to maintain quality standards.Key responsibilities and accountabilities 1. Conduct Systems Audits every first week in a month.2. Daily QA morning meeting to discuss & guide problems faced by QA/QC team.3. Qualification and evaluation of Suppliers and Subcontractors.4. Analysing customer complaints and Internal rejection on weekly basis. Actively involved in Troubleshooting of process problems and monitor the non-conformities.5. Plan, conduct and face internal and external quality audits to verify compliance with quality standards and identify improvement areas.6. Plan and review the annual training calendar. Arrange three department-wise trainings monthly. Check and verify the effectiveness of the training and share feedback with management on a monthly basis.7. Implement Work management practice for planning, execution, and monitoring of all tasks and activities required to accomplish jobs on time.Knowledge, skills, and abilities Education and experience Diploma / BE Should be Technically Sound.Work Days Friday Weekly offSunday Working