Quality Assurance Manager

Position: Senior QA Specialist / QA Manager

Location: Gandhinagar (GNR)

Job Overview:

We are looking for a highly skilled and experienced Quality Assurance (QA) professional to lead

and maintain robust quality systems, ensuring compliance with both regulatory requirements

and customer standards. This role is critical in driving continuous improvement and audit

readiness across the organization.

The ideal candidate will have a strong background in QA practices within the pharmaceutical or

equipment manufacturing sector, with proven experience in documentation, audits, and

compliance.

Key Responsibilities:

1. Quality Systems Management

Oversee and maintain site-wide quality systems and the complete lifecycle of GMP

documentation.

Manage SOP implementation and control, including the issuance, retrieval, and

archiving of logbooks and controlled documents.

2. Batch & Product Quality Assurance

Review Batch Manufacturing Records (BMR), master documents, and ensure adherence

to production quality standards.

Issue and manage Certificates of Quality (COQ) and Certificates of Analysis (COA) for all

finished product batches.

3. Audit & Regulatory Compliance

Lead preparations for internal, customer, and regulatory audits to ensure compliance

and audit readiness.

Manage Corrective and Preventive Actions (CAPA), track progress, and verify

effectiveness.

4. Vendor and Training Oversight

Conduct vendor audits and maintain supplier quality assurance.

Develop and deliver QA-related training programs across departments to support

regulatory compliance and quality awareness.

5. Documentation & Reporting

Compile and analyze quality metrics for management review.

Manage and resolve customer complaints, internal deviations, and non-conformances

through thorough root cause analysis and CAPA.

Qualifications:

Graduate/Postgraduate in Science (Chemistry, Biology, Microbiology, Biotechnology) or

B.Pharm/M.Pharma.

8 10 years of experience in QA, preferably in the pharmaceutical or equipment

manufacturing sectors.

Key Skills & Competencies:

Strong proficiency in SOP writing, document control, and GMP practices.

In-depth knowledge of audit handling, CAPA processes, and root cause analysis tools.

Excellent communication skills and ability to collaborate across functions.

Strong organizational skills with attention to detail and ability to manage multiple

priorities.

Effective leadership and team management abilities.

Professional demeanor with a solution-oriented mindset.