QA Specialist

Aveva Drug Delivery Systems; Hyderabad; On-site; INR 3,977,670 - 5,303,561; Full time

Job summary

Aveva Drug Delivery Systems in Hyderabad, Telangana, seeks a Quality Assurance Specialist to ensure quality and regulatory compliance of pharmaceutical testing activities, including review and approval of testing protocols and reports, and coordination with CMOs for investigations related to testing.

The ideal candidate will have a solid QA background in pharma, strong attention to detail, and familiarity with FDA/EMA guidelines, CAPA management, and documentation control.

Qualifications

• 3+ years in pharmaceutical, biotech, or related QA roles.
• Experience reviewing and approving testing protocols and reports.
• Familiarity with FDA, EMA guidelines and experience coordinating with CMOs.

Responsibilities

• Review and approve testing protocols and reports to ensure regulatory compliance.
• Coordinate with CMOs to oversee investigations and CAPA implementation.
• Lead quality investigations including root cause analysis and documentation.
• Maintain documentation and records per regulatory standards.
• Support internal audits and SOP development related to QA activities.

Skills

Strong analytical skills

Excellent communication

Detail-oriented

CAPA management

Education

Bachelor’s degree in Chemistry/Biology/Pharmaceutical Sciences

Advanced degree or certification in QA

Job description

Job Details

Job Location: Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072

Salary Range: $30.00 - $40.00 Hourly

Job Shift: Day

Job Summary

The Quality Assurance Specialist will play a critical role in ensuring the quality and compliance of pharmaceutical testing activities. This position is responsible for the review and approval of testing protocols and reports, as well as coordinating with Contract Manufacturing Organizations (CMOs) to oversee investigations related to the execution of testing protocols. The ideal candidate will have a strong background in quality assurance within the pharmaceutical industry, with excellent attention to detail and a deep understanding of regulatory requirements.

Key Responsibilities

• Review and Approval of Testing Protocols and Reports:
  • Review and approve testing protocols, including stability, validation, and method development protocols, ensuring they meet regulatory requirements and company standards.
  • Critically evaluate testing reports to ensure correctness, completeness, and compliance of data, confirming that results align with protocol objectives.
  • Collaborate with cross‑functional teams—Quality Control, Regulatory Affairs, and R&D—to address discrepancies or concerns identified during the review process.
• Coordination with Contract Manufacturing Organizations (CMOs):
  • Serve as the primary Quality Assurance liaison with CMOs, ensuring that all testing activities comply with approved protocols and regulatory standards.
  • Coordinate and oversee investigations of deviations, non‑conformances, or out‑of‑specification results during CMO execution.
  • Ensure CMOs implement corrective and preventive actions (CAPA) and verify their effectiveness.
• Regulatory Compliance:
  • Ensure all reviewed documents comply with applicable regulations (FDA, EMA, and other global standards).
  • Stay informed of regulatory changes and update protocols and reports accordingly.
• Investigation Management:
  • Lead and manage quality investigations, including root cause analysis, CAPA development, and documentation.
  • Work closely with CMOs to ensure timely and thorough resolution of quality concerns.
• Documentation and Record Keeping:
  • Maintain accurate records of all QA activities—protocol and report reviews, investigation findings, and CAPA documentation.
  • Ensure all documentation is controlled and maintained per company procedures and regulatory requirements.
• Continuous Improvement:
  • Identify opportunities for process improvement in protocol execution, report review, and quality investigation practices.
  • Participate in internal audits and contribute to SOP development related to QA activities.
• Training and Compliance:
  • Provide training to internal teams and CMOs on quality standards, regulatory requirements, and best practices.
  • Maintain comprehensive training records for all personnel involved in testing activities.

Qualifications

• Education: Bachelor’s degree in a scientific discipline (Chemistry, Biology, Pharmaceutical Sciences) or related field. Advanced degree or certification in QA preferred.
• Experience:
  • 3+ years in pharmaceutical, biotech, or related QA roles.
  • Experience reviewing and approving testing protocols and reports.
  • Familiarity with FDA, EMA guidelines and experience coordinating with CMOs.
• Skills:
  • Strong analytical skills for evaluating data and identifying QA issues.
  • Excellent communication and interpersonal skills.
  • Detail‑oriented and committed to regulatory compliance.
  • Effective problem‑solving, especially for CAPA management.

Preferred Qualifications

• Experience managing quality investigations and conducting root cause analysis.
• Familiarity with GMP and GLP.
• Knowledge of quality management systems and electronic document management (EDMS).

Working Conditions

• Office‑based position with occasional travel to CMOs or partner sites.
• Ability to work across multiple time zones as needed.