Quality Assurance

Job Description: APL HC -4 (Formulation)

Department: Quality Assurance (QA)
Location: Aurobindo Pharma Formulation Plant
Employment Type: Full-Time

Job Purpose

To maintain, execute, and continuously improve Quality Systems at the formulation plant. This role ensures strict compliance with cGMP, international regulatory guidelines (USFDA, MHRA, EU, WHO), and internal standard operating procedures. The successful candidate will drive operational excellence within the QMS, Validation, and Market Complaints sections.

Quality Management Systems (QMS)

• Investigation Strategy & Execution: Author and lead investigations for plant-level deviations, non-conformances, and environmental excursions. Ensure immediate logging in enterprise software (e.g., TrackWise) within 24 hours of event discovery.
• OOS & OOT Remediation: Drive Phase II manufacturing investigations for Out of Specification (OOS) and Out of Trend (OOT) events. Interrogate manufacturing parameters, material handling histories, and human-machine interface (HMI) logs to verify or eliminate production errors. [1]
• Root Cause Analysis (RCA) Methodologies: Apply specialized investigative frameworks explicitlyincluding Ishikawa (Fishbone) tracking, 5-Why progression, Fault Tree Analysis (FTA), and Failure Mode and Effects Analysis (FMEA). Do not accept generic "human error" designations; drill down to systematic system flaws.
• CAPA Architecture: Construct highly targeted Corrective and Preventive Actions (CAPA) with cross-functional alignment. Ensure that actions address the root cause and are structured with quantifiable parameters for Effectiveness Checks post-implementation.
• Change Control Oversight: Perform multi-faceted impact assessments for change requests modifying manufacturing recipes, production machinery capacities, batch size scalings, primary container configurations, and manufacturing site software.
• Audit Defense & Compliance: Compile comprehensive regulatory compliance dossiers against health authority inspection findings (such as USFDA 483s, MHRA deficiencies, or Customer Audits). Own the active collection and readiness of documents on the front line during regulatory events.

Validation & Qualification:

• Lifecycle Process Validation: Plan, draft, and oversee the physical execution of Stage 2 (Process Qualification / PPQ) and Stage 3 (Continued Process Verification / CPV) protocols for Oral Solid Dosages (OSD), liquids, or sterile injectables.
• Equipment & Facility Qualification: Direct the execution of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) frameworks for critical manufacturing systems (e.g., Fluid Bed Dryers, High-Shear Granulators, Multi-Layer Tablet Compressions, Blenders, and Blister Packing Machines).
• Utility & Facility Validation: Enforce ongoing verification programs for clean utilities, including HVAC air-flow mapping, Water for Injection (WFI) loops, and Purified Water (PW) distributions.
• Data Integrity Enforcement (ALCOA+): Review raw instrument data, analytical batch logs, and automated audit trails. Verify that all manual and electronic source records satisfy data safety benchmarks perfectly before final release.
• Vendor Qualification Matrix: Review technical files, supply agreements, and audit questionnaires to qualify vendors handling active pharmaceutical ingredients (APIs), key excipients, and primary packaging materials.

Market Complaints & Complaint Handling:

• Intake & Categorization: Process all inbound Market Complaints and Product Technical Complaints (PTC). Execute triage and rank items immediately according to global safety, quality, or counterfeit indicator risks.
• Retain Sample Analysis: Coordinate with the QC department to retrieve, inspect, and analyze targeted batch reserve/retain samples under controlled conditions. Compare physical presentation directly against the complaint profile.
• Batch Document Forensics: Perform deep reviews across all relevant historical documents, including Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), environmental room logs, in-process testing logs, and original release analytical reports.
• Report Writing: Compose highly analytical, technical Market Complaint Investigation Reports (MCIR). Ensure they contain clean scientific rationales and are completed within the targeted regulatory window.
  

Required Technical System Competencies:

Candidates must demonstrate direct, autonomous mastery over standard pharmaceutical enterprise software suites and regulatory documentation frameworks:

• Enterprise QMS Software: Hands-on command over TrackWise, Veeva Systems, or Documentum.
• Analytical Systems: Familiarity with LIMS (Laboratory Information Management Systems) and data extraction methodologies from chromatography systems (e.g., Empower).
• Industrial Automation Logs: Competency in extracting and evaluating automated recipe trends, alarm logs, and audit trails from plant floor SCADA and PLC architectures.
• Global Regulatory Compendia: Working command over 21 CFR Part 210/211 (USFDA), EU GMP Annex 11 (Computerised Systems), EU GMP Annex 15 (Qualification and Validation), and ICH Quality Guidelines (Q8, Q9, Q10).