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Job Description – Officer QA

Department: Quality Assurance
Designation: Officer – QA
Reporting To: Assistant Manager / Manager – QA
Location: Navi Mumbai

1. Job Purpose

To support Quality Assurance activities in a pharmaceutical analytical testing laboratory, with specific responsibility for Computer System Validation (CSV) execution and documentation, analytical data review, review of instrument qualification/calibration records and ensuring compliance with applicable GMP, GLP, data integrity and laboratory quality requirements.

2. Key Responsibilities

A. Computer System Validation (CSV)

• Support and execute Computer System Validation activities for laboratory computerized systems in accordance with approved validation procedures and applicable regulatory expectations.
• Review and/or execute validation documents including:
  • User Requirement Specifications (URS)
  • Functional/Design Specifications
  • Risk Assessments
  • Validation Plans
  • Configuration/Installation/Operational Qualification documents
  • User Acceptance Testing (UAT)
  • Traceability Matrix
  • Validation Summary Reports
• Participate in assessment of GxP applicability, data integrity, audit trails, electronic records and electronic signatures.
• Execute or coordinate validation test cases and document test results, deviations and evidence.
• Review validation documentation and ensure that requirements are adequately tested and traceable.
• Support periodic review, change control, access management and revalidation activities for computerized systems.
• Work with IT, laboratory and system vendors to resolve validation-related issues.

B. Instrument Qualification Data Review

• Review qualification documentation for laboratory instruments and computerized analytical systems.
• Review DQ/IQ/OQ/PQ and requalification records, as applicable.
• Verify that qualification protocols and reports adequately address predefined acceptance criteria.
• Review calibration and qualification certificates, raw data, test results and associated deviations.

C. Analytical Data Review

• Perform independent review of analytical data generated from laboratory instruments such as HPLC, GC, LC-MS/MS, GC-MS, ICP-MS, IC, KF, UV and other analytical systems.
• Review raw data, chromatograms, spectra, calculations, worksheets, system-generated reports and analytical results for completeness, accuracy and compliance with approved methods and SOPs.
• Verify calculations, integration parameters, system suitability results, sequence details, sample preparation records and acceptance criteria.
• Review electronic data for ALCOA+ principles and data integrity compliance.
• Identify atypical results, discrepancies, missing data, audit trail concerns and potential data integrity issues and escalate them appropriately.
• Review analytical data packages and support QA disposition/release activities where applicable.

D. Quality Management System

• Support implementation and maintenance of the laboratory QMS in accordance with applicable requirements such as GMP, GLP, ISO/IEC 17025 and data integrity expectations, as applicable.
• Support internal audits and regulatory inspection readiness activities.
• Review SOPs, forms, protocols and quality documents related to laboratory operations.
• Monitor compliance with approved SOPs and identify opportunities for continual improvement.
• Support training and awareness initiatives related to data integrity and QA requirements.

E. Regulatory Compliance & Data Integrity

• Maintain awareness of current regulatory expectations relating to data integrity, computerized systems, electronic records and analytical laboratory controls.
• Ensure that electronic and paper records are complete, attributable, legible, contemporaneous, original/true copy, accurate and readily retrievable.
• Review audit trails and other electronic records as defined by procedures and risk assessment.
• Identify and escalate potential data integrity risks or compliance gaps.

3. Qualification & Experience

Education:

• Bachelor's or Master's degree in Pharmacy, Chemistry, Analytical Chemistry, Pharmaceutical Sciences or a related discipline.

Experience:

• 2–5 years of relevant experience in Quality Assurance within a pharmaceutical, CRO, analytical testing or contract laboratory environment.
• Hands-on experience in analytical data review is essential.
• Experience in Computer System Validation (CSV) execution and/or review is preferred.
• Experience in instrument qualification/validation data review is preferred.
• Experience with HPLC/GC and other analytical laboratory systems will be an advantage.
• Exposure to ALIMS/LIMS, CDS systems such as Chromeleon/OpenLab and electronic document management systems is desirable.

4. Technical Competencies

• Strong understanding of analytical laboratory operations and analytical data.
• Good knowledge of GMP/GLP and data integrity principles (ALCOA+).
• Understanding of CSV lifecycle and risk-based validation principles.
• Ability to review qualification protocols, raw data and reports critically.
• Knowledge of electronic records, audit trails and electronic signatures.
• Good documentation and report-writing skills.
• Proficiency in MS Office and electronic quality systems.

5. Behavioural Competencies

• Strong attention to detail and analytical thinking.
• Ability to identify inconsistencies and compliance risks.
• Independent and objective approach to data review.
• Good communication and interpersonal skills.
• Ability to work collaboratively with Analytical, IT and external service providers.
• Strong commitment to data integrity, compliance and quality.
• Ability to manage multiple activities and meet timelines.

6. Key Performance Indicators

• Timely completion and quality of analytical data reviews.
• Timely completion of CSV validation activities and documentation.
• Accuracy and effectiveness of instrument qualification data review.
• Number and quality of compliance gaps identified proactively.
• Compliance with applicable SOPs and regulatory requirements.
• Effectiveness in supporting audit and inspection readiness.

Working at ALS

The ALS team is a diverse and dedicated community united by our passion to make a difference in the world.

Our values are important to us, and shape how we work, how we treat each other and how we recognise excellence. 

At ALS, you’ll be supported to develop new skills and reach your full potential. We invest in our people with programs and opportunities that help you build a diverse career with us. 

We want everyone to have a safe, flexible and rewarding career that makes a positive impact on our people, the planet and our communities.

Everyone Matters

ALS is proud to be an equal opportunity employer and is committed to fostering an inclusive work environment where the strengths and perspectives of each employee are both recognised and valued.

ALS also welcomes applications from people with all levels of ability. Reasonable adjustments to support candidates throughout the recruitment process are available upon request. 

Eligibility
To be eligible to work at ALS you must be a Citizen or Permanent Resident of the country you are applying for, or either hold or be able to obtain, a valid working visa.

How to apply
Please apply on-line and provide a resume & cover letter that best demonstrate your motivation and ability to meet the requirements of this role.