QA Validation - Executive

Promea Therapeutics Pvt. Ltd.; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Job summary

Promea Therapeutics Pvt. Ltd. is seeking a QA Validation Executive in Hyderabad, India. The role encompasses ensuring compliance of validation activities related to equipment and processes while adhering to GMP guidelines.

Ideal candidates will have a Bachelor’s or Master’s degree in relevant fields and 2–5 years of experience in QA Validation. Strong knowledge of GMP regulations and experience in qualification activities are essential. A focus on improving processes and documenting compliance is key to the role.

Qualifications

• 2–5 years of experience in QA Validation within biotechnology, biopharmaceutical, or pharmaceutical manufacturing environment.
• Strong knowledge of GMP/cGMP regulations.

Responsibilities

• Review and approve validation protocols and reports for equipment qualification.
• Ensure validation activities are executed according to approved protocols.
• Participate in risk assessments related to validation activities.
• Prepare, review, and maintain validation documentation.

Skills

Knowledge of GMP/cGMP regulations

Experience in IQ/OQ/PQ qualification activities

Understanding of process validation

Knowledge of deviation management

Good documentation skills

Proficiency in MS Office

Education

Bachelor's or Master's degree in Biotechnology or related field

Tools

Quality management systems

Job description

The QA Validation Executive is responsible for reviewing, coordinating, and ensuring compliance of validation activities related to equipment, utilities, computerized systems, processes, and cleaning validation in accordance with GMP, GLP, regulatory requirements, and company quality standards.

Key Responsibilities

• Review and approve validation protocols and reports for equipment qualification (IQ, OQ, PQ).
• Review and approve validation protocols and reports for utility qualification (HVAC, Water Systems, Compressed Air, etc.).
• Review and approve validation protocols and reports for process validation.
• Review and approve validation protocols and reports for cleaning validation.
• Ensure validation activities are executed according to approved protocols and schedules.
• Coordinate with Production, Engineering, QC, and Regulatory teams during validation projects.

Quality Assurance Compliance

• Ensure compliance with GMP, cGMP, WHO, US FDA, EMA, and applicable regulatory guidelines.
• Participate in risk assessments related to validation activities.
• Review change controls, deviations, CAPAs, and their impact on validation status.
• Maintain validation master plans and validation lifecycle documentation.

Documentation & Audits

• Prepare, review, and maintain validation documentation.
• Support internal, customer, and regulatory audits.
• Ensure data integrity and documentation compliance.
• Track validation commitments and periodic reviews.

Process Improvement & Training

• Identify opportunities for process improvement and validation optimization.
• Participate in training programs and quality improvement initiatives.

Required Qualifications

• Bachelor's or Master's degree in Biotechnology, Microbiology, Biochemistry, Life Sciences, Pharmacy, or a related field.
• 2–5 years of experience in QA Validation within a biotechnology, biopharmaceutical, vaccine, or pharmaceutical manufacturing environment.

Required Skills

• Strong knowledge of GMP/cGMP regulations.
• Experience in IQ/OQ/PQ qualification activities.
• Understanding of process validation and cleaning validation.
• Knowledge of deviation management, CAPA, and change control systems.
• Familiarity with regulatory guidelines such as US FDA, EU GMP, WHO, and ICH.
• Good documentation and report‑writing skills.
• Proficiency in MS Office and quality management systems.
• Experience with sterile manufacturing or biologics production.
• Knowledge of data integrity requirements (ALCOA+ principles).
• Experience supporting regulatory inspections and audits.