Corporate Quality Assurance (CQA)- Sr. Executive/ Asst. Manager

Job Title: Sr. Executive/ Asst. Manager- Corporate Quality Assurance (CQA)

Department:

Job Purpose:

To ensure consistent quality across all pharmaceutical manufacturing processes and sites by implementing and monitoring corporate-level quality systems and regulatory compliance. This role supports global compliance, audits, and continuous quality improvement activities in accordance with cGMP, ICH, US FDA, EU, MHRA, and other regulatory standards.

Key Responsibilities:

1. Quality System Oversight

• Monitor and evaluate the implementation of Quality Management Systems (QMS) at manufacturing sites.
• Support the development and revision of corporate quality SOPs.
• Review and approve site-specific SOPs to ensure alignment with corporate quality policies.

2. Compliance and Auditing

• Conduct internal and external GMP audits (vendors, third-party manufacturers, CMOs).
• Track and ensure closure of audit observations and CAPA implementation.
• Assist in regulatory inspections and respond to regulatory queries.

3. Documentation and Review

• Review and approve key quality documents: BMR/BPR, validation protocols, change controls, deviations, and OOS investigations.
• Ensure compliance with data integrity requirements.

4. Training and Development

• Provide training to QA teams on corporate policies, data integrity, and regulatory requirements.
• Support continuous improvement and knowledge sharing initiatives across the organization.

5. Regulatory Support

• Participate in dossier review for regulatory submissions (ANDA, NDA, MA).
• Support QA due diligence for new product launches and tech transfers.

6. Risk Management & Quality Metrics

• Evaluate quality risks and trends across sites using KPIs and metrics.
• Prepare and present periodic quality performance reports to senior management.

Qualifications and Skills:

Education:

• B.Pharm/ M.Pharm / M.Sc. in a relevant field.

Experience:

• 34 years in Quality Assurance, with exposure to corporate QA or multi-site operations.

Technical Skills:

• In-depth knowledge of GMP regulations (ICH, US FDA, EU, WHO, etc.)
• Experience in auditing, CAPA, QMS, and regulatory inspections
• Strong documentation and analytical skills
• Proficient in MS Office

Soft Skills:

• Strong communication and interpersonal skills
• Problem-solving and decision-making abilities
• Attention to detail and high ethical standards

Preferred Certifications (optional):

• Certified Quality Auditor (CQA – ASQ or equivalent)

  Role & responsibilities

Preferred candidate profile