MUMBAI · FULLTIME
Manager - Central Quality Assurance (Vendor Management & Compliance)
ACG Group
Mumbai · onsite · Posted 3d ago
Sourced from
Undisclosed5–9 yrsfulltimeMumbai
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Section · 01
About this role
Position Title: Manager - Central Quality Assurance (Vendor Management & Compliance), ACG Capsules
Organization Context
Position Title:
Manager - Central Quality Assurance (Vendor Management & Compliance), ACG Capsules
Employee Name:
Grade:
M05 or M06
Department:
Quality and Regulatory Affairs
Location:
Kandivali
Reports to:
Head - Central Quality Assurance, ACG Capsules
Reported by:
2 - Sr. Executives
ACG is the world s only integrated pharma manufacturing solutions company. We are headquartered in Mumbai, India. ACG has a presence in over 100 countries with its products and services that strive to provide world-class technology across multiple domains. We offer a complete range of solutions beginning with empty capsules; granulation and tablet coating; capsule filling; tabletting; packaging films; blister packing and carton packing to the end-of-line solutions and track and trace systems.
We have an opportunity in ACG Capsules of a Manager - Vendor Management & Compliance, Central Quality Assurance, Quality and Regulatory Affairs.
- Job Objective
- To lead and govern vendor management and compliance processes across ACG Capsules, ensuring a robust and compliant vendor base.
- Drive Quality Management Systems (QMS) while strengthening audit readiness, regulatory compliance, and continuous improvement across sites.
- Primary responsibilities
Strategy & Planning
- Define and drive vendor management strategy to ensure availability of qualified and compliant vendors
- Establish governance framework for vendor qualification, performance monitoring, and requalification
- Drive standardisation of vendor management across sites
- Lead audit readiness strategy for internal, external, and regulatory audits
- Identify risks in vendor quality and compliance systems and implement mitigation plans
- Drive digitalisation and process improvement initiatives in vendor management and DMS
Functional
- Oversee vendor qualification, evaluation, and approval processes in alignment with regulatory and internal standards
- Review and approve vendor specifications in alignment with ACG quality requirements
- Ensure effective management of vendor documentation and compliance through systems/portals
- Review and approve SOPs related to vendor management and QMS
- Ensure readiness and compliance of raw material and packaging material specifications
- Oversee planning and execution of vendor audits and internal audits across sites
Core
- Own end-to-end vendor compliance and QMS performance across ACG Capsules
- Drive cross-functional alignment with Procurement, Regulatory, Operations, and Quality teams
- Lead root cause analysis for critical deviations, audit observations, and vendor-related issues
- Drive implementation of preventive and corrective actions for vendor complaints to strengthen quality systems
- Establish performance metrics for vendor quality and audit outcomes
- Act as escalation point for critical vendor and compliance-related issues
- Own and monitor regulatory and certification compliance across applicable India and overseas locations, including FDA activities, ISO, EXCiPACT, FSSAI, FDS and other relevant requirements.
- Ensure timely renewal and maintenance of manufacturing licences, regulatory approvals and applicable quality certifications to support uninterrupted compliant operations.
People Development
- Lead and develop the vendor management and QMS team
- Drive capability building on GxP practices, audit readiness, and regulatory compliance
- Build a culture of quality, compliance, and continuous improvement across teams
Regulatory & Certification Compliance
- Ensure compliance with applicable FDA, FSSAI, FDS and other regulatory requirements across India and overseas locations.
- Ensure timely completion of FDA activities, regulatory audits and inspections wherever required.
- Ensure valid manufacturing licences, regulatory approvals and certifications are maintained.
- Oversee applicable ISO, EXCiPACT and other quality certifications for India and overseas locations.
- Ensure timely closure of regulatory and certification-related observations and CAPAs.
Any other additional responsibility could be assigned to the role holder from time to time as a standalone project or regular work. The same would be suitably represented in the Primary responsibilities and agreed between the incumbent, reporting officer and HR.
- Key Result Areas
- Vendor compliance and approval cycle time
- Audit effectiveness (internal, vendor, regulatory) and closure timelines
- Change Control, Deviation, and CAPA closure timelines and effectiveness
- Quality of investigations and reduction in repeat deviations
- Timely and accurate completion of customer/regulatory questionnaires
- Vendor performance and quality metrics
- Key Interfaces
Internal Interfaces
External Interfaces
- Purchase Team
- Regulatory Team
- Projects Team
- Operations
- Corporate Quality
- Vendors
- Auditors
Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
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Section · 02
Skills
CapsulesGranulationpeople developmentPerformance monitoringCapability BuildingauditsCapsule FillingCAPAChange ControlBlister PackingManufacturingoperationsmaintenancecompliancePharmaPackaging MaterialCoating
Section · Company
About ACG Group
ACG Group
Pharma
1964
62 years old
Mumbai, Maharashtra
India
₹7.8L PA avg
Avg at ACG Group
About
ACG
https://www.acg-world.com/
ACG PAM Pharma Technologies Pvt. Ltd.
We are globally admired group, pioneering new technologies and products, delighting stakeholders and nurturing talent to attain inclusive growth.
We serve Global Pharmaceutical Industry bringing together the best of ACG and all our stakeholders.
www.acg-world.com
Employee ratings
10 reviews
4.0/ 5
Culture
4.2
Career growth
3.4
Work-life
4.5
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