Talent.com
Cadila Pharmaceuticals Limited
AGM:- Quality AssuranceCadila Pharmaceuticals Limited • Jūnāgadh, IN
AGM:- Quality Assurance

AGM:- Quality Assurance

Cadila Pharmaceuticals Limited • Jūnāgadh, IN
18 days ago
Job description
  • Lead and maintain the Pharmaceutical Quality System (PQS) by establishing, implementing, monitoring, and continuously improving quality systems in compliance with ICH Q7, ICH Q9(R1), ICH Q10, applicable cGMP regulations, and company quality policies to ensure a state of continuous regulatory compliance. - Should be very much conversant with the implementation and monitoring of computerized systems validation (CSV), Caliber LIMS / QMS / DMS. - Provide independent Quality Unit oversight to the plant for all GMP operations, including manufacturing, warehousing, laboratories, engineering, validation, utilities, computerized systems, contract service providers, and supply chain activities, ensuring quality decisions remain independent of operational and commercial influences. - Authorize / do the release or rejection of APIs, intermediates, raw materials, packaging materials (where applicable), and quality records after ensuring compliance with approved specifications, validated processes, regulatory requirements, and GMP documentation. - Ensure effective implementation and governance of Quality Management Systems, including document control, deviations, investigations, CAPA, change control, risk management, complaints, recalls, annual product quality reviews, training, supplier qualification, and management review. - Ensure robust investigation and resolution of quality events, including deviations, Out-of-Specification (OOS), Out-of-Trend (OOT), laboratory incidents, customer complaints, and critical quality issues through scientifically sound root cause analysis and effective CAPA implementation. - Provide Quality Assurance oversight and approval of qualification and validation activities, including facilities, utilities, equipment, processes, cleaning, analytical methods, computerized systems, transport, and continued process verification to ensure ongoing validated state and regulatory compliance. - Establish and sustain an effective Quality Risk Management (QRM) program by integrating risk-based decision making across product lifecycle activities, ensuring risks are identified, assessed, mitigated, communicated, and periodically reviewed in accordance with ICH Q9(R1). - Ensure data integrity and documentation compliance by implementing controls aligned with ALCOA++ principles, Good Documentation Practices (GDP), electronic record requirements, audit trail review, controlled access, data governance, and periodic data integrity assessments. - Lead inspection readiness and regulatory compliance activities, including preparation, management, and response to inspections and audits conducted by regulatory authorities, customers, and corporate quality organizations, ensuring timely closure of observations and regulatory commitments. - Develop, qualify, monitor, and periodically evaluate suppliers, contract manufacturers, contract laboratories, and service providers through risk-based qualification, quality agreements, performance monitoring, audits, and ongoing compliance oversight. - Review and approve quality-impacting changes by ensuring comprehensive change control, regulatory impact assessment, validation requirements, risk evaluation, and implementation of appropriate controls before execution. - Monitor quality performance through quality metrics, trend analysis, Annual Product Quality Reviews (APQR / PQR), management reviews, and continuous improvement initiatives, driving operational excellence and sustained GMP compliance throughout the organization. - Establish and maintain an effective quality culture by ensuring GMP training, competency development, quality awareness, ethical practices, regulatory knowledge, and cross-functional engagement while promoting continuous learning and accountability at all organizational levels. - Responsible and supporting new product introduction, technology transfer, lifecycle management, contamination control strategies, digital quality systems, regulatory intelligence, and implementation of evolving global GMP expectations and industry best practices.
Create a job alert for this search

AGM:- Quality Assurance • Jūnāgadh, IN

Similar jobs

Sales Engineer

EDAN Instruments, Inc.Jūnāgadh, Republic Of India, IN

New Delhi(Delhi), Rajasthan(Jaipur), Uttar Pradesh(Lucknow), Karnataka(Bengaluru), Maharashtra(Mumbai), Maharashtra, Gujarat, Madhya, Pradesh, Chhattisgarh, Odisha, Jharkhand, North, East Provinces... Show more

 • Promoted

Sales Engineer

HeadSpinJunagadh, Gujarat, India

Job Description NetWitness is revolutionizing how organizations detect, investigate, and respond to cyber threats.As a leader in SIEM (Security Information and Event Management) and NDR (Network D... Show more

 • Promoted

Customer Success Manager - SMA

BrightEdgeJunagadh, Gujarat, India

About the Company BrightEdge Location: Bengaluru / Mumbai / Delhi / Pune (Remote) Experience: 3-8 years Timings - EST / PST (4:30 PM to 1:30 AM IST) Customer Success Manager Level Senior Indi... Show more

 • Promoted

Enterprise Account Executive - US

Aelum Consulting - ServiceNow Premier PartnerJunagadh, Gujarat, India

About Aelum Consulting Aelum Consulting is a ServiceNow Partner helping enterprises accelerate digital transformation through workflow automation, enterprise service management, AI-driven solution... Show more

 • Promoted

Area Sales Manager

DEONICS TECHNOLOGIES PRIVATE LIMITEDJunagadh, Gujarat, India

Company Description DEONICS Technologies Private Limited provides a broad range of technology-related services that help businesses manage and optimize their IT infrastructure.The company offers s... Show more

 • Promoted

Account Executive - Global

ShipdayJunagadh, Gujarat, India

The company: At Shipday, we are arming the rebels in local delivery space.Shipday's mission is to democratize access to easy, affordable local delivery solutions for small businesses all over the w... Show more

 • Promoted

Cerner Support Analyst

LuxoftJunagadh, Gujarat, India

Project Description: Support clients in the operation, maintenance, and optimization of Oracle Cerner EHR environments.This role is designed for early-career professionals who are eager to grow the... Show more

 • Promoted

Enterprise Account Executive - Middle East & APAC

Aelum Consulting - ServiceNow Premier PartnerJunagadh, Gujarat, India

Aelum Consulting is a ServiceNow Partner helping enterprises accelerate digital transformation through workflow automation, enterprise service management, AI-driven solutions, and consulting servic... Show more

 • Promoted

Sales Engineer

dataPARCJunagadh, Gujarat, India

GENERAL SUMMARY: The Sales Engineer role is a crucial piece to driving additional business through sales channels, as well as direct.The primary responsibilities include providing technical support... Show more

 • Promoted

Senior Consultant (Power Platform & COE Governance)

Atidan TechnologiesJunagadh, Gujarat, India

Responsibilities 5 + years in Power Platform (admin + delivery); proven CoE governance experience in large enterprises (10K+ users).Hands-on CoE Starter Kit implementation and operations (install, ... Show more

 • Promoted

Growth & Lead Generation Manager (Remote)

First Choice Business Debt SolutionsJunagadh, Gujarat, India
Remote

Company Description First Choice Business Debt Solutions is dedicated to helping small businesses, particularly Construction, Trade, and Trucking companies, overcome financial hardships caused by M... Show more

 • Promoted

Account Manager

NewnovationJunagadh, Gujarat, India

CSAM – Digital Sales - IC role Customer Segment: SMB – North America Location: Remote, India About the Role The CSAM – Digital Sales - IC role is focused on managing a large book of existing SMB... Show more

 • Promoted

Sales Leader: Plant Engineering Services for U.S. Market

Creative Synergies GroupJunagadh, Gujarat, India

Creative Synergies Group Overview Creative is a leading global technology services firm delivering innovative solutions that synergies our deep engineering domain expertise and Digital Engineering... Show more

 • Promoted

Customer Success Manager

TestGrid.ioJunagadh, Gujarat, India

Job Title: Customer Success Manager Role Summary : The CSM will play a critical role in ensuring customer satisfaction, product adoption, and long-term success.This role requires a strong blend o... Show more

 • Promoted

Xurrent Administrator

DataLunixJunagadh, Gujarat, India

Key Responsibilities Administer and configure Xurrent ITSM platform; manage roles, workflows, SLAs, incident/problem/change modules; optimize automation, dashboards, and service catalog; troublesho... Show more

 • Promoted

Account Executive

TestGrid.ioJunagadh, Gujarat, India

Account Executive (AE) Experience: 3–7 years in B2B SaaS Sales (with European market exposure preferred) Department: Sales & Growth About TestGrid TestGrid is a leading provider of end-to-end au... Show more

 • Promoted

Head Baker

SilverseaJunagadh, Gujarat, India

Position Summary The Head Baker at Silversea Cruises is a senior culinary leadership role responsible for overseeing onboard bakery operations and delivering exceptional, luxury-level baked goods.T... Show more

 • Promoted

Account Manager

TestGrid.ioJunagadh, Gujarat, India

Job Title: Account Manager Role Summary: The Account Manager (AM) will be the primary owner of commercial health, revenue retention, and account expansion at TestGrid.This role bridges the gap ... Show more

 • Promoted

Claims Operations Executive

hotsourcedJunagadh, Gujarat, India

Claims Operations Executive India (Remote) | Full-Time | Permanent | InsurTech Placed by Hotsourced – connecting top South African talent with world-class global companies Our client is a rapidly ... Show more

 • Promoted

Credit Risk Analytics & Product Management

EliteRecruitmentsJunagadh, Gujarat, India

Job Summary: We are seeking an experienced and analytically driven professional to head the credit product and policy design, launch and management of our embedded finance portfolio as the Director... Show more