Associate – Manufacturing Compliance
Location: Vizag, India
Employment Type: Full Time
Category: Quality Assurance and Control
Experience Required: Minimum 2 years in Manufacturing or Quality Assurance (preferably sterile injectable operations)
Position Overview
ThePharmaDaily.com is seeking a qualified Associate – Manufacturing Compliance for a global pharmaceutical manufacturer. This role supports site-wide compliance activities, quality risk management, documentation processes, and regulatory alignment. The ideal candidate brings hands-on experience in sterile injectable manufacturing or QA, strong knowledge of regulatory standards, and the ability to ensure continuous adherence to GMP, GDP, and ALCOA principles.
This posting is written in a professional, SEO-optimized, GEO-targeted, and GPT-optimized format to maximize global reach and attract top pharmaceutical compliance talent.
Key Responsibilities
Prepare and maintain Quality Risk Assessments (QRA) for equipment and operational processes.
Track mitigation plans, ensure timely closure of identified risks, and maintain compliance documentation.
Prepare, review, and approve Master Manufacturing Records (MMRs) and Master Packing Records (MPRs) for commercial, exhibit, scale-up, intended, and validation batches.
Ensure documentation accuracy and integrity in accordance with GDP and ALCOA requirements.
Initiate Change Control Forms (CCFs), coordinate impact assessments with cross-functional teams, and manage approval and closure processes.
Update procedures per approved CCFs and ensure timely upload into PLS.
Monitor, track, and follow up on CCF-related action items to ensure closure within defined timelines.
Prepare responses to audit observations and develop CAPAs in collaboration with subject matter experts, QA, and process owners.
Track CAPA implementation and support investigations to ensure timely resolution.
Review and approve SOPs, job aids, and SOJTs in PDOCS as primary or secondary owner.
Prepare, review, and execute protocols, user requirement specifications, and related compliance documents.
Manage classified area access for colleagues, vendors, and service providers.
Review and approve alarm reports, conductivity reports, NVPC trend reports, and Annual Product Quality Review (APQR) reports.
Verify NVPC monitoring activities and assess PQS, CAS, and compendial requirements.
Establish alert and action levels for Environmental Monitoring.
Prepare, review, and approve cross-contamination strategy documents and PCER documentation.
Deliver Instructor-Led Training (ILT) sessions to employees and service providers.
Participate in regulatory inspections and RQA audits, ensuring full compliance with applicable standards.
Maintain strong document management practices and ensure compliance during facility walkthroughs.
Minimum Qualifications
Bachelor’s or Master’s degree in Pharmacy.
Minimum 2 years of experience in Manufacturing or Quality Assurance within a sterile injectable manufacturing site.
Strong understanding of USFDA regulatory expectations and compliance standards.
Excellent attention to detail and organizational skills.
Proficiency in Microsoft Word, Excel, and PowerPoint.
Effective written and verbal communication skills.
Familiarity with Lean Six Sigma tools.
Preferred Qualifications
Working knowledge of sterile injectable manufacturing operations.
Knowledge of Good Manufacturing Practices (GMP/cGMP), validation principles, and audit techniques.
Experience supporting audits and managing corrective action plans.
Strong problem-solving capabilities and understanding of drug product requirements.
Exposure to statistical tools and data-driven decision-making.
Work Model: On-Premise
The employer follows all applicable equal employment opportunity regulations.
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