ALS is hiring for the position of Executive – QA in Navi Mumbai, India. The role focuses on quality assurance, GMP/GLP compliance, document and record review, audits, regulatory compliance, training, and handling laboratory investigations, deviations, CAPA, and OOS investigations.

Job Details

Position

Executive – QA

The Executive – QA will be responsible for reviewing quality documentation and records, supporting GMP/GLP compliance, conducting inspections and audits, maintaining regulatory compliance, providing training, and handling quality investigations.

Key Responsibilities

1. Document and Record Review

• Review analysis records, MOA, and SOPs for compliance with GMP and regulatory requirements.
• Approve or reject procedures and specifications affecting the identity, strength, quality, and purity of drug products or drug substances.
• Review qualification and calibration records through hard-copy and electronic data.
• Review software qualification documents, including IQ, OQ, and user acceptance testing.

2. Inspection and Auditing

• Inspect laboratory areas to ensure compliance with GMP/GLP standards.
• Conduct internal audits of systems, processes, and documentation.
• Participate in regulatory inspections and audits conducted by health authorities.
• Independently handle customer audits.
• Defend established policies and investigate cited non-compliances.
• Prepare compliance reports and implement corrective and preventive actions.

3. Training and Compliance

• Provide training to staff on GMP, SOPs, regulatory requirements, and updates.
• Ensure personnel are adequately trained and maintain competency in their assigned roles.

4. Regulatory Compliance

• Maintain current knowledge of pharmaceutical regulations and industry standards.
• Monitor new and updated regulatory guidance.
• Develop policies and systems based on applicable regulatory requirements.
• Update or implement policies and procedures to maintain laboratory compliance.

5. Deviations, CAPA, OOS and Investigations

• Assist with investigations involving deviations, non-conformances, and product quality complaints.
• Facilitate implementation of CAPA.
• Document findings, results, and corrective actions according to regulatory requirements.
• Approve laboratory investigations, change controls, and hypothesis testing plans for OOS investigations.

Eligibility / Qualifications

The supplied job description does not provide specific educational qualifications or experience requirements. Candidates should therefore review the official vacancy requirements before applying.

Required Skills

The role involves knowledge and/or experience related to:

• Quality Assurance
• GMP and GLP compliance
• SOP review
• Pharmaceutical regulations
• Laboratory inspections
• Internal and customer audits
• Regulatory inspections
• CAPA
• OOS investigations
• Deviations and non-conformances
• Change control
• Laboratory investigations
• Qualification and calibration records
• Software qualification
• Regulatory guidance monitoring
• Staff training and competency

Application Details

Application Link