Apply on Kit Job: kitjob.in/job/4q5jva

Key Responsibilities

Analytical Quality Assurance Activities

- Review analytical records, raw data, chromatograms, spectra, laboratory notebooks, and supporting documents for accuracy, completeness, and
- GMP compliance.
- Ensure analytical testing activities comply with approved specifications, test methods, SOPs, and regulatory expectations.
- Verify laboratory documentation practices in accordance with Valuable Documentation Practices (GDP).
- Review and approve Certificates of Analysis (COA), analytical reports, and laboratory records.

Laboratory Compliance & Data Review

- Perform second-person review of analytical data generated in QC laboratories.
- Review analytical worksheets, instrument audit trails, logbooks, and electronic records.
- Ensure compliance with Data Integrity requirements and ALCOA+ principles.
- Monitor laboratory practices to identify compliance gaps and recommend corrective actions.

OOS, OOT & Laboratory Investigation Management

- Review and support investigations related to:
- Out of Specification (OOS)
- Out of Trend (OOT)
- Laboratory Incidents
- Atypical Results
- Analytical Deviations
- Participate in root cause investigations and evaluate scientific justifications.
- Ensure implementation and effectiveness of CAPAs arising from investigations.

Method Validation & Analytical Lifecycle Support

- Review protocols and reports related to:
- Method Validation
- Method Verification
- Method Transfer
- Method Development Support
- Cleaning Validation Analytical Studies
- Ensure compliance with ICH and regulatory expectations during analytical validation activities.

Stability Program Support

- Review stability study protocols and reports.
- Monitor stability sample testing and documentation practices.




- Ensure compliance with ICH Stability Guidelines.
- Support trending and evaluation of stability data.

Data Integrity & Computerized Systems Compliance

- Ensure laboratory computerized systems comply with Data Integrity requirements.
- Review audit trails and electronic records.
- Verify compliance with 21 CFR Part 11 requirements.
- Participate in Data Integrity assessments and remediation activities.

Change Control, CAPA & Quality Systems

- Review analytical impact assessments for Change Controls.
- Support CAPA implementation and effectiveness verification.
- Participate in quality risk assessments related to analytical processes.
- Ensure closure of assigned quality system records within timelines.

Regulatory Inspection & Audit Readiness

- Support internal audits, customer audits, and regulatory inspections.
- Prepare laboratory compliance documentation for audits.
- Respond to audit observations related to analytical quality systems.
- Participate in inspection readiness programs.

Cross-Functional Collaboration Work closely with:

- Quality Control
- Analytical Development
- Quality Assurance
- Manufacturing
- Validation
- Regulatory Affairs
- Support quality culture and compliance initiatives across departments.

Educational Qualifications

Essential

M.Sc. (Chemistry / Analytical Chemistry / Organic Chemistry) OR M.Pharm

Preferred

Additional certifications in GMP, Quality Systems, Data Integrity, or Analytical Sciences.

Experience Requirements

Essential

37 years of experience in Analytical Quality Assurance, Quality Assurance, or Quality Control within API pharmaceutical manufacturing.

Preferred

Experience supporting regulated markets such as USFDA, MHRA, EMA, WHO, PMDA, ANVISA, or TGA.

Exposure to regulatory audits and inspections.

Apply on Kit Job: kitjob.in/job/4q5jva

📌 Associate - Analytical Quality Assurance (AQA) - API (Visakhapatnam)
🏢 Laurus Labs
📍 Visakhapatnam