ALS is hiring an Officer – QA for its Quality Assurance team in Navi Mumbai, Maharashtra. This opportunity is suitable for professionals with 2–5 years of experience in pharmaceutical QA, CRO, analytical testing or contract laboratory environments.
The role focuses on analytical data review, Computer System Validation (CSV), instrument qualification, GMP/GLP compliance, ALCOA+ data integrity and laboratory Quality Management Systems (QMS).
Candidates with a Bachelor’s or Master’s degree in Pharmacy, Chemistry, Analytical Chemistry, Pharmaceutical Sciences or a related discipline can apply, provided they meet the experience requirements.
Job Details
| Particular | Details |
|---|---|
| Company | ALS |
| Job Title | Officer – QA |
| Department | Quality Assurance |
| Job Requisition ID | R8076 |
| Location | Navi Mumbai, Maharashtra |
| Experience | 2–5 years |
| Qualification | Bachelor’s/Master’s in Pharmacy, Chemistry, Analytical Chemistry, Pharmaceutical Sciences or related field |
| Job Type | Full-time |
| Work Area | Quality Assurance / Analytical Laboratory |
| Key Skills | CSV, Analytical Data Review, GMP, GLP, ALCOA+, Data Integrity, HPLC, GC |
About the Officer – QA Role
The Officer – QA will support Quality Assurance activities in a pharmaceutical analytical testing laboratory. A major part of the position involves Computer System Validation (CSV), review of analytical data and laboratory computerized systems, instrument qualification records and compliance with GMP, GLP and data integrity requirements.
The selected candidate will work closely with Analytical, IT teams and external system vendors while supporting validation, quality documentation, audits and inspection readiness.
Key Responsibilities
1. Computer System Validation
The Officer – QA will:
- Support and execute CSV activities for laboratory computerized systems.
- Review and execute URS, Functional/Design Specifications and Risk Assessments.
- Support Validation Plans and qualification documentation.
- Participate in Installation Qualification (IQ), Operational Qualification (OQ) and related validation activities.
- Support User Acceptance Testing (UAT).
- Prepare and review Traceability Matrices and Validation Summary Reports.
- Participate in GxP applicability and data integrity assessments.
- Review audit trails, electronic records and electronic signatures.
- Execute validation test cases and document results, deviations and supporting evidence.
- Support periodic reviews, change controls, access management and revalidation.
- Coordinate with IT, laboratory teams and vendors to resolve validation issues.
2. Instrument Qualification Data Review
Responsibilities include:
- Reviewing DQ/IQ/OQ/PQ and requalification records.
- Reviewing laboratory instrument qualification protocols and reports.
- Verifying predefined acceptance criteria.
- Reviewing calibration and qualification certificates.
- Checking raw data, test results and associated deviations.
- Assessing qualification documentation for completeness and compliance.
3. Analytical Data Review
The position requires strong experience in analytical data review. The candidate may review data generated from:
- HPLC
- GC
- LC-MS/MS
- GC-MS
- ICP-MS
- Ion Chromatography (IC)
- Karl Fischer (KF)
- UV and other analytical systems
The role includes reviewing chromatograms, spectra, calculations, worksheets, system-generated reports, sequence details, sample preparation records and analytical results.
The Officer – QA will also identify atypical results, discrepancies, missing data, audit-trail concerns and potential data integrity issues and escalate them appropriately.
4. Quality Management System
The selected candidate will support:
- Laboratory QMS implementation and maintenance.
- GMP, GLP and ISO/IEC 17025 compliance activities.
- Internal audits and regulatory inspection readiness.
- SOP, form, protocol and quality-document review.
- Compliance monitoring.
- Training and awareness initiatives related to QA and data integrity.
5. Regulatory Compliance & Data Integrity
The role requires knowledge of ALCOA+ data integrity principles, electronic records and laboratory controls.
Candidates should be capable of ensuring that records are complete, attributable, legible, contemporaneous, original/true copy, accurate and readily retrievable.
ALS Officer QA Eligibility
Educational Qualification
Candidates should have a:
- Bachelor’s degree in Pharmacy, Chemistry, Analytical Chemistry, Pharmaceutical Sciences or a related discipline; or
- Master’s degree in Pharmacy, Chemistry, Analytical Chemistry, Pharmaceutical Sciences or a related discipline.
Experience Required
- 2–5 years of relevant QA experience.
- Experience in pharmaceutical, CRO, analytical testing or contract laboratory environments.
- Hands-on experience in analytical data review is essential.
- Experience in Computer System Validation (CSV) is preferred.
- Experience reviewing instrument qualification/validation data is preferred.
- Experience with HPLC, GC and other analytical laboratory systems is advantageous.
Technical Skills
Candidates should ideally have knowledge of:
- GMP and GLP
- ALCOA+ and data integrity
- Computer System Validation lifecycle
- Risk-based validation
- Electronic records and electronic signatures
- Audit trails
- Analytical laboratory operations
- Qualification protocols and reports
- HPLC and GC
- ALIMS/LIMS
- Chromeleon/OpenLab CDS
- Electronic document management systems
- Microsoft Office
Behavioural Skills
ALS is looking for candidates who demonstrate:
- Strong attention to detail.
- Analytical and critical-thinking abilities.
- Ability to identify compliance risks.
- Independent and objective approach to data review.
- Strong communication and interpersonal skills.
- Ability to collaborate with Analytical, IT and external service providers.
- Commitment to quality and data integrity.
- Ability to manage multiple activities and meet deadlines.
Why Consider This ALS QA Job?
This Officer – QA position provides exposure to several important areas of modern pharmaceutical laboratory quality, including CSV, computerized laboratory systems, analytical data review, instrument qualification, QMS and data integrity.
The ALS careers information supplied for this position also highlights opportunities to develop new skills, build a diverse career and work in an environment focused on quality, safety and professional development.
ALS states that it is an equal opportunity employer and welcomes applications from people with different levels of ability, with reasonable adjustments available during the recruitment process.
Salary
The job description does not disclose a salary. For SEO/schema purposes, an indicative market-based range of ₹4.5 lakh–₹8 lakh per annum may be used for a 2–5 year Officer-level QA position in the Navi Mumbai pharmaceutical/analytical laboratory market.
Note: This is an estimated range, not an employer-confirmed salary. Candidates should verify the actual compensation with ALS during the recruitment process.