Location: Nalagarh, Himachal Pradesh
Department: Quality Assurance
Job Summary:
The QA Executive will ensure that all pharmaceutical products manufactured comply with the regulatory standards set by Indian authorities such as the CDSCO, DCGI, and international regulatory bodies. This role involves ensuring adherence to GMP guidelines as per Schedule M and other Indian pharmaceutical regulations, managing quality documentation, and collaborating with the production, QC, and regulatory teams.
Key Responsibilities:

• Regulatory Compliance:
• Ensure that manufacturing processes comply with Good Manufacturing Practices (GMP) as per Schedule M and other regulatory requirements from Indian regulatory bodies (CDSCO, DCGI).
• Implement and maintain the company’s quality management system (QMS) in line with Indian and international standards.
• Assist in preparing, reviewing, and approving Standard Operating Procedures (SOPs) to align with Indian pharmaceutical regulations.
• Batch Review and Release:
• Review batch manufacturing records (BMRs) and batch packaging records (BPRs) for completeness and compliance before batch release.
• Coordinate with production and quality control teams to ensure timely release of batches as per Indian regulatory timelines.
• Documentation and Record Maintenance:
• Ensure proper documentation of all quality-related processes and maintain records according to regulatory norms in India.
• Maintain and update quality assurance documentation, such as deviation reports, CAPA reports, and change control records.
• Audits and Inspections:
• Prepare and participate in internal and external audits, including audits by Indian regulatory authorities such as the CDSCO.
• Assist in responding to audit findings and implementing corrective and preventive actions (CAPA) based on Indian and international guidelines.
• Training and Awareness:
• Conduct regular GMP and Schedule M training sessions for production staff, ensuring compliance with Indian pharmaceutical standards.
• Ensure awareness and adherence to quality protocols across all teams, including compliance with Drugs & Cosmetics Act provisions.
• Quality Risk Management:
• Conduct risk assessments for potential quality issues in the production process as per local regulatory requirements.
• Implement corrective measures to mitigate identified risks and ensure product quality.
• Deviation and Incident Handling:
• Investigate deviations and product quality issues, ensuring timely closure of deviations, CAPAs, and other non-conformances in compliance with Indian regulations.

Key Skills and Qualifications:

• Bachelor’s/Master’s degree in Pharmacy, Chemistry, or related field.
• Mandatory 2-4 years of experience in quality assurance specefically in an Indian pharmaceutical manufacturing environment.
• Strong understanding of Indian pharmaceutical regulations, including Schedule M, CDSCO, and DCGI guidelines.
• Knowledge of international standards (such as WHO GMP, USFDA) is an added advantage.
• Excellent attention to detail and strong problem-solving abilities.
• Ability to manage multiple tasks and meet tight deadlines.
• Proficient in MS Office and quality management software.
• Profient in written and verbal English and local languages, with the ability to collaborate across teams.

Preferred Qualifications:

• Experience with regulatory audits conducted by Indian authorities (e.g., CDSCO, DCGI).
• Familiarity with Indian pharmaceutical quality risk management principles and tools.

Job Type: Full-time
Pay: ₹30,000.00 - ₹50,000.00 per month
Benefits:

• Commuter assistance

Schedule:

• Day shift

Supplemental Pay:

• Performance bonus

Ability to commute/relocate:

• Nalagarh, Himachal Pradesh: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• pharmaceutical QA: 2 years (Required)
• QA Pharmaceutical: 2 years (Required)

Work Location: In person