QA Executive - Analytical Review & Compliance

Why This Role Matters

In pharmaceutical manufacturing, especially within Oral Solid Dosage (OSD) facilities, analytical quality oversight is critical to ensuring patient safety, product consistency, and regulatory compliance. Every batch released to the market must meet stringent quality standards supported by scientifically verified analytical data.

The Analytical QA Executive role at Ontop Pharmaceuticals Private Limited plays a pivotal role in strengthening data integrity, reviewing analytical outputs, and ensuring that laboratory operations comply with GLP and cGMP standards. This position directly impacts batch release decisions, regulatory inspection readiness, and overall quality system robustness.

For professionals with hands-on analytical experience in OSD plants, this opportunity offers strong exposure to quality systems, compliance management, and regulatory-driven manufacturing operations in WHO-GMP and Schedule M compliant facilities.

Job Description

Ontop Pharmaceuticals Private Limited, a WHO-GMP and Schedule M compliant pharmaceutical manufacturer with facilities in Bengaluru and Hyderabad, is expanding its Quality Assurance team. The organization specializes in high-quality oral solid dosage formulations and is seeking experienced professionals for the role of Analytical QA Executive.

The selected candidate will be responsible for reviewing analytical data, handling investigations related to OOS and OOT results, ensuring GLP and cGMP compliance, and supporting regulatory adherence within the OSD manufacturing setup. The role demands technical expertise in chromatographic and spectroscopic data review, strong documentation practices, and the ability to maintain high standards of data integrity.

This position is ideal for candidates with 2–3 years of experience in Analytical QA or QC within OSD plants who are looking to advance their careers in quality assurance and compliance-driven environments.

Key Features of the Role

Opportunity to work in WHO-GMP and Schedule M compliant manufacturing facilities.
Direct exposure to analytical review processes in OSD manufacturing.
Hands-on involvement in OOS/OOT investigations and CAPA management.
Strong focus on regulatory compliance and data integrity practices.
Career growth opportunities in quality assurance within a structured pharmaceutical setup.
Positions available in Bengaluru and Hyderabad manufacturing sites.

Responsibilities Required

Perform analytical QA oversight activities in an OSD manufacturing plant to ensure compliance with internal quality standards and regulatory requirements.
Review analytical data generated from techniques such as HPLC, GC, UV spectrophotometry, and dissolution testing for accuracy, completeness, and compliance.
Verify raw data, chromatograms, system suitability parameters, and calculations to ensure correctness and adherence to validated methods.
Handle Out of Specification (OOS) and Out of Trend (OOT) investigations in coordination with QC and production teams, ensuring root cause analysis and timely closure.
Initiate and track Corrective and Preventive Actions (CAPA) to address deviations and improve system robustness.
Ensure compliance with Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP) across analytical operations.
Maintain strict data integrity standards in accordance with regulatory expectations, including audit trail review and documentation control.
Participate in internal audits and support regulatory inspections by providing required documentation and analytical justifications.
Review analytical method validation, verification, and stability study reports to ensure compliance with regulatory and internal guidelines.
Collaborate with cross-functional teams including QC, production, and QA to maintain seamless quality operations.
Ensure adherence to SOPs, quality management systems (QMS), and documentation control procedures.
Support continuous improvement initiatives to enhance laboratory compliance and efficiency.

Qualifications

Candidates must demonstrate strong analytical knowledge, regulatory awareness, and hands-on OSD plant experience.

Educational Requirements:

Bachelor's degree in Pharamcy (B.Pharm), Matser's degree in Pharmacy (M.Pharm), or related life sciences qualification from a recognized institution.

Experience and Skills:

2–3 years of experience in Analytical QA or QC, preferably within an OSD manufacturing plant.
Proficiency in reviewing analytical data from HPLC, GC, UV, and dissolution studies.
Strong understanding of OOS, OOT handling, and CAPA implementation.
Knowledge of GLP, cGMP, Schedule M, and WHO-GMP compliance standards.
Familiarity with data integrity principles and regulatory documentation practices.
Strong attention to detail and analytical problem-solving skills.
Good documentation, communication, and cross-functional coordination abilities.
Ability to manage multiple analytical reviews and investigations within defined timelines.
Preference may be given to local candidates from Bengaluru or Hyderabad and immediate joiners.

Salary Insights

While exact compensation is not disclosed, typical salary ranges for Analytical QA Executives with 2–3 years of experience in Bengaluru or Hyderabad fall between ₹4–7 lakhs per annum, depending on expertise, technical proficiency, and negotiation.

Compensation may include:
Competitive industry-aligned salary
Opportunities for performance-based growth
Exposure to regulated manufacturing environments
Professional development within QA systems

Company Overview

Ontop Pharmaceuticals Private Limited is a well-established pharmaceutical manufacturer operating WHO-GMP and Schedule M compliant facilities in Bengaluru and Hyderabad. The company specializes in producing high-quality oral solid dosage (OSD) formulations with a strong emphasis on regulatory compliance, quality excellence, and data integrity.

With a focus on robust quality systems and manufacturing standards, Ontop Pharmaceuticals provides professionals with opportunities to grow in compliance-driven environments while contributing to the production of safe and effective pharmaceutical products.

FAQs

1. What experience is required for this role?
   Candidates must have 2–3 years of experience in Analytical QA or QC, preferably in an OSD plant.

2. Is OSD experience mandatory?
   Experience in an OSD manufacturing setup is strongly preferred.

3. What analytical techniques should candidates be familiar with?
   HPLC, GC, UV spectrophotometry, and dissolution testing data review experience is required.

4. Are local candidates preferred?
   Yes, candidates based in Bengaluru or Hyderabad are preferred, along with immediate joiners.

5. What compliance knowledge is essential?
   Knowledge of GLP, cGMP, Schedule M, WHO-GMP, OOS/OOT handling, CAPA, and data integrity is essential.

Application Tips

Clearly highlight your OSD plant experience in your resume.
Mention specific analytical instruments handled and data review exposure.
Include examples of OOS investigations and CAPA involvement.
Demonstrate understanding of data integrity and regulatory compliance principles.
Prepare to discuss real-time analytical review scenarios and compliance challenges during the interview.