Assistant Manager - QA Engineer

Dear Candidate

Greetings from Medley Pharmaceuticals Ltd,

We have an urgent job opening for the position of Assistant Manager in QA Engineer, Instrumentation at our Daman Formulation Plant.

Interested candidate can share their CV's on [email removed]

Key Responsibilities

• Plan and manage qualification (DQ, IQ, OQ, PQ) of analytical instruments such as HPLC, GC, UV-Vis, FTIR, dissolution apparatus, KF titrator, balances, pH meters, and other QC instruments.
• Review and approve qualification protocols, test data, deviations, and summary reports.
• Maintain the instrument qualification master list, requalification schedule, and calibration status.
• Verify calibration traceability and review calibration certificates against acceptance criteria.

1. Validation Documentation

• Prepare, review, and execute IQ/OQ/PQ protocols and reports.
• Prepare and review Validation Master Plan (VMP) elements, URS, traceability matrices, and risk assessments (ICH Q9, FMEA).
• Ensure all validation activities follow approved protocols, with deviations documented and resolved before report approval.

1. PLC, SCADA, HMI and Computerized Systems

• Provide QA oversight for PLC, SCADA, HMI, and other computerized systems used in manufacturing and utilities.
• Support computerized system validation (CSV) per GAMP 5, 21 CFR Part 11, and EU Annex 11.
• Review system classification, validation plans, functional and design specifications, test scripts, and validation summary reports.
• Verify user access controls, role definitions, password policy, electronic signatures, backup/restore, and disaster recovery.
• Review audit trails periodically and ensure review records are maintained.

c) Data Integrity and Compliance

• Ensure compliance with ALCOA+ across instruments, logbooks, electronic records, and validation documents.
• Perform data integrity gap assessments for lab and manufacturing systems and follow up on remediation.
• Verify that standalone instruments have controlled access, time/date protection, and audit trail functionality.

Quality Systems

• Review and approve SOPs, change controls, deviations, incidents, OOS/OOT investigations (instrument-related), and CAPAs.
• Perform impact and risk assessments for changes to equipment, software, or instruments.
• Review periodic review reports and requalification outcomes.

1. Cross-Functional Coordination

• Coordinate with QC, Engineering, Automation, IT, Production, and vendors for qualification and validation activities.
• Provide QA guidance on URS and vendor documentation (FAT/SAT, vendor audits where applicable).

Audit and Inspection Support

• Support internal audits, customer audits, and regulatory inspections (USFDA, EU GMP, WHO, CDSCO).
• Prepare validation and CSV documentation for inspections and respond to observations.
• Track commitments from audit observations to timely closure.

Training and Team Development

• Train QA, QC, and engineering staff on qualification, CSV, data integrity and GDP.
• Guide and mentor junior QA executives and engineers.

Qualification and Experience

• Education: B.E. / B.Tech or Diploma in Instrumentation Engineering (Electronics / Instrumentation & Control)
• Experience: 6-12 years in the pharmaceutical industry, with relevant QA/validation exposure
• Mandatory: Hands-on experience in QC instrument qualification and IQ/OQ/PQ documentation, Production and Utilities
• Preferred: Experience in USFDA / EU GMP-inspected facilities; exposure to PLC/SCADA and CSV projects