Senior Executive / Assistant Manager AQA

Company Description

ALS is a global leader providing comprehensive testing solutions across various industries worldwide. Our dedicated international teams utilize state-of-the-art technologies and innovative methodologies to deliver high-quality testing services. ALS offers personalized solutions, supported by local expertise, to help clients leverage data-driven insights for a safer and healthier world.

Role Description

This is a full-time on-site role for a Senior Executive / Assistant Manager AQA based in Hyderabad. The Senior Executive / Assistant Manager AQA will be responsible for overseeing and ensuring quality assurance processes, conducting audits, and implementing improvements. Key tasks include analyzing data, preparing reports, and collaborating with teams to enhance service delivery and compliance with industry standards.

·        - Review and approve analytical data, test reports, and laboratory documentation.

·        - Ensure adherence to GLP, GMP, and applicable regulatory guidelines (ICH, WHO, USFDA).

·        - Conduct internal audits and support external audits (regulatory and client).

·        - Monitor calibration and maintenance of analytical instruments (HPLC, GC, UV, IR, HRMS).

·        - Investigate and document deviations, OOS, and CAPA.

·        - Assist in drafting and reviewing SOPs, protocols, and validation reports.

·        - Provide training to lab personnel on QA systems and regulatory standards.

·        - Support method validation and technology transfer activities.

·        - Maintain and manage quality documentation and records.

·        - Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, or related field.

·        - 7 to 8 years of experience in Analytical QA in a pharmaceutical or testing laboratory.

·        - Strong knowledge of regulatory guidelines and quality systems.

·        - Proficiency in handling analytical instruments and interpreting data.

·        - Excellent documentation, communication, and organizational skills.

·        - Ability to work independently and collaboratively in a fast-paced environment.

·        - Experience with LIMS or other laboratory data management systems.

·        - Familiarity with ISO 17025 or NABL accreditation processes.

·        - Proven experience in audit preparation and handling.