AGM - Quality Assurance

AGM - QA

Role is for QMS, audits, compliance, documentation, and regulatory alignment.

• We are Looking for someone to review/approve all QMS documents (Quality Manual, SOPs, VMPs, Specs).

• Full ownership of ISO 9001 / 15378 / 13485 compliance that's textbook QMS territory.

• Person acts as the Management Representative a pure QMS governance role.

• Leading internal/external audits + being the face for regulatory inspections.

• Driving CAPA, deviations, OOS/OOT, change controls — again all QMS core components.

• Ensuring QMS implementation & continuous improvement across the org.

LOCATION: Vapi/Valsad

EDUCAITON:

1. Bachelors degree in Pharmacy, Chemistry, Life Sciences, or related field.
2. Masters degree in Quality Management, Business Administration, or related discipline (preferred).
   

Must Have's:

• Proven record of 10-15 years of experience in Quality Assurance, with at least 5 years in a leadership role.

• Experience with QMS implementation, audits, and customer interactions within regulated industries.

Role

1. Review, approve, and ensure alignment of key quality management system documents (e.g., Quality Manual, SOPs).
2. Master Plans, Product Specifications) with relevant ISO standards (ISO 9001, ISO 15378, ISO 13458) regulatory guidelines.
3. Drive continuous improvement and ensure the QMS is fully implemented and maintained across the organization.
4. Lead the organizations adherence to statutory, legal, and international quality standards, ensuring all processes comply with current regulations.
5. Act as the primary point of contact for external audits and regulatory inspections, managing audit preparation, execution, and follow-up actions.
6. Establish and nurture a quality-focused culture within the organization, ensuring all departments are aligned with the companys quality objectives and best practices.
7. Promote employee engagement in quality-related activities and ensure that quality standards are maintained across all operational levels.
8. Serve as the management representative for quality assurance, handling customer queries, complaints, and providing necessary documentation in compliance with quality standards.
9. Lead internal and external audits, ensuring full compliance with QMS and regulatory standards and Address audit observations, ensuring corrective and preventive actions (CAPA) are promptly implemented.
10. Manage risk assessments and identify opportunities for continuous improvement in quality management systems.
11. Approve and oversee the release of batches, including Batch Manufacturing Records (BMR) and Certificates of Analysis (COA), ensuring compliance with quality and regulatory standards.
12. Approve change control processes, deviations, Out of Specification (OOS) or Out of Trend (OOT) investigations, and corrective actions to mitigate risks.
13. Implement and monitor CAPA initiatives to address quality issues and drive continuous improvement in processes, products, and systems.
14. Ensure safety, environmental, and health guidelines are integrated into quality management practices.
15. Provide leadership and mentorship to the Quality Assurance team, fostering professional development and ensuring adequate training on quality systems, procedures, and standards.

Knowledge

1. In-depth knowledge of ISO standards, GMP and regulatory compliance
2. Good communication skills
3. Experience Range: 15+ Years
4. Experience with QMS implementation, audits, and dealing with customers

Competencies

1. Strong leadership, problem-solving, and decision-making capabilities.
2. In-depth knowledge of ISO standards, GMP, and regulatory compliance.
3. Ability to manage multiple projects and ensure timely, quality-focused delivery.

Skills

1. Strong verbal and written communication skills to coordinate with vendors, internal teams, and tax authorities.
2. Sound technical knowledge and basic knowledge of MS Office.