Company Description

Biotics Lab is a leading pharmaceutical marketing company in India, with a strong presence since 2005 and focused expertise in Critical Care, Cardiac & Diabetic Care, Neuro & Gastro Care, and Ayurveda & Nutraceuticals. Over the past two decades, the company has built a reputation for trust, dedication, and service, forming long-term partnerships with healthcare professionals and communities.

Biotics

Lab has a significant footprint across the southern states of Kerala, Karnataka, and Tamil Nadu, driven by a customer-centric and ethical approach. The organization is recognized as one of the fastest-growing pharmaceutical companies in India, committed to quality and accessible healthcare solutions. Team members join a culture that values innovation, continuous improvement, and responsible healthcare delivery.

Job Summary

Responsible for ensuring quality compliance of Finished Dosage Formulations (FDF) sourced from third-party manufacturers for international markets. The role involves vendor qualification, batch document review, product release coordination, quality documentation management, and ensuring compliance with applicable GMP and export market requirements.

Key Responsibilities

Quality Assurance & Compliance

- Ensure products supplied by contract manufacturers comply with approved specifications and regulatory requirements.
- Review and approve batch manufacturing records, batch packing records, Certificates of Analysis (CoA), and related quality documents.
- Monitor compliance with GMP, WHO-GMP, and applicable international quality standards.
- Support implementation and maintenance of Quality Management Systems (QMS).

Vendor Qualification & Management

- Conduct vendor qualification and periodic performance reviews of contract manufacturing partners.
- Coordinate vendor audits and ensure timely closure of audit observations.
- Review GMP certificates, quality agreements, and technical documents from manufacturers.
- Monitor supplier quality performance and compliance status.

Product Release & Documentation





- Verify batch documentation and facilitate batch release for export shipments.
- Review product specifications, stability data, validation documents, and quality-related records.
- Maintain quality documentation, SOPs, change controls, deviations, CAPAs, and investigation records.
- Ensure proper archival and retrieval of quality documents.

Regulatory & Cross-Functional Coordination

- Support Regulatory Affairs with quality documentation required for product registrations and renewals.
- Coordinate with Sourcing, Supply Chain, Regulatory, and Manufacturing partners on quality-related matters.
- Assist in handling customer complaints, product quality issues, and market feedback.

Quality Systems & Continuous Improvement

- Participate in internal audits, vendor audits, and quality reviews.
- Track and monitor deviations, OOS/OOT results, CAPAs, and change controls.
- Support quality improvement initiatives and compliance enhancement programs.

Qualifications & Experience

- B.Pharm / M.Pharm / B.Sc. / M.Sc. in Life Sciences, Chemistry, or related field.
- 2–5 years of experience in Quality Assurance within the pharmaceutical industry.
- Experience with Finished Dosage Formulations (FDF) and third-party manufacturing operations preferred.

Required Skills

- Strong understanding of GMP, WHO-GMP, GDP, and pharmaceutical quality systems.
- Knowledge of batch release processes and quality documentation.
- Familiarity with vendor qualification, audits, deviations, CAPA, and change control systems.
- Solid analytical, documentation, and problem-solving skills.
- Proficiency in Microsoft Office applications.
- Effective communication and stakeholder management skills.

Key Performance Indicators (KPIs)

- Timely review and release of export batches.
- Vendor compliance and audit performance.
- Closure of deviations, CAPAs, and quality investigations within timelines.
- Reduction in quality-related complaints and non-conformances.
- Compliance with GMP and quality system requirements.
- Accuracy and completeness of quality documentation.

Employment Type: Full-Time | Based in: Kochi | Send your resume to [email protected]

📌 QA Executive – Finished Dosage Formulations (FDF) Exports (Kochi)
🏢 Biotics Lab - India
📍 Kochi