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Company Description Audit & Align CGMP compliance services provide quality manpower to the pharmaceutical sector, along-with a strong emphasis on regulatory excellence and audit readiness. The organization focuses on conducting rigorous GMP and mock audits, strengthening documentation and traceability, and championing continuous improvement and risk-based thinking. Core services include QMS assignments, retrospective document review, and design of SOPs and qualification protocols for equipment and instruments in GMP environments. The team also develops and optimizes e-tools such as Trackwise, SAP, LIMS, CDS, and e-DMS to enhance quality control laboratory efficiency and compliance. Overall, Audit & Align supports clients in elevating QC documentation, improving traceability, and reinforcing a robust culture of quality and compliance.
Role Description The Quality Control Analyst, Pharmaceuticals will be responsible for performing routine and non-routine analysis of raw materials, in-process samples, and finished products in accordance with CGMP and company SOPs. This full-time, on-site role based in Solapur includes executing laboratory tests, operating and maintaining analytical instruments, documenting results accurately, and ensuring data integrity and traceability. The analyst will collaborate with Quality Assurance and other cross-functional teams to support investigations, deviations, and CAPAs, and contribute to continuous improvement of laboratory processes. Daily activities also involve participating in method validation or verification, supporting regulatory and internal audits, and maintaining a safe, compliant, and inspection-ready laboratory environment.
Qualifications
- Candidates should possess strong Analytical Skills and the ability to interpret complex data sets and test results.
- Candidates should possess solid Quality Control skills, including experience with CGMP-compliant testing and documentation practices.
- Candidates should possess hands-on Laboratory Skills, including sample handling, preparation, and adherence to safety procedures.
- Candidates should possess familiarity with Laboratory Equipment such as HPLC, GC, UV-Vis spectrophotometers, and other QC instruments.
- Candidates should possess foundational Quality Assurance skills, including understanding of QMS, SOPs, and audit requirements.
- Relevant qualifications include a degree in Pharmacy, Chemistry, Microbiology, or a related scientific discipline.
- Additional beneficial skills include knowledge of electronic quality systems (e.g., LIMS, e-DMS), attention to detail, and strong written documentation abilities.
- Ability to work collaboratively in cross-functional teams, manage priorities, and maintain high standards of integrity and compliance is expected.
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