QA - Process Validation and Customer Complaint

USV; Poicha; On-site; INR 1,200,000 - 2,500,000; Full time

Job summary

USV, a leading pharmaceutical firm, seeks an experienced QA professional with 8–12 years in pharma/biotech manufacturing to drive quality assurance, process validation, and regulatory compliance. The role emphasizes PPQ/CPV leadership, QRM, CAPA, and technical documentation across audits and investigations.

Ideal candidates will manage CAPA workflows, author SOPs and VMPs, and coordinate audits per USFDA, EU GMP, and ICH guidelines, using TrackWise, ValGenesis, MES, and Minitab tools.

Qualifications

• 8 to 12 years of hands-on Quality Assurance experience in Pharmaceutical or Biotech manufacturing.
• Experience in handling client communications, regulatory audits, and technical writing.

Responsibilities

• Lead PPQ, CPV, and technology transfer/scale-up activities across projects.
• Manage Quality Risk Management (QRM) using FMEA and HACCP to set CPPs and CQAs.
• Oversee lifecycle of customer complaints and deviations with RCA.
• Own CAPA workflow through implementation and effectiveness verification.
• Host and facilitate internal, vendor, and regulatory audits under USFDA, EU GMP and ICH guidelines.
• Author and approve SOPs, Validation Master Plans, validation protocols, and investigation reports.
• Operate TrackWise, ValGenesis, MES, and statistical tools like Minitab.

Skills

Quality Assurance

Regulatory audits

Process Validation

CPV & PPQ

QRM (FMEA, HACCP)

CAPA Management

RCA (5 Whys, Fishbone)

Technical Documentation

eQMS & Software

Minitab

Tools

TrackWise

ValGenesis

MES

Minitab

Job description

• Experience: 8 to 12 years of hands-on Quality Assurance experience in Pharmaceutical or Biotech manufacturing.
• Organizational Stability: Minimum of 2+ years of continuous service in the current organization (candidates with frequent job hops will be disqualified).
• Communication: Fluent written and spoken English proficiency for handling client communications, technical writing, and regulatory audits.
• Process Validation & Tech Transfer: Proven leadership in drafting, executing, and reporting end-to-end Process Performance Qualification (PPQ), Continuous Process Verification (CPV), and technology transfer/scale-up activities.
• Quality Risk Management (QRM): Applied expertise in using FMEA and HACCP tools to establish Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
• Customer Complaints & RCA: Full lifecycle management of customer complaints and deviations using advanced RCA tools (5 Whys, Fishbone, Fault Tree Analysis).
• CAPA Management: Direct responsibility for executing the complete Corrective and Preventive Action (CAPA) workflow through to effectiveness verification.
• Regulatory & Audit Expertise: Demonstrated success hosting and facilitating internal, vendor, and regulatory audits under USFDA (21 CFR Parts 11, 210, 211), EU GMP, and ICH (Q8, Q9, Q10) guidelines.
• Technical Documentation: Experience authoring and approving SOPs, Validation Master Plans (VMP), validation protocols, and comprehensive investigation reports.
• eQMS & Software Proficiency: High proficiency operating within TrackWise (QMS), ValGenesis (VMS), MES, and statistical tools like Minitab.