Role & responsibilities

1.Laboratory Testing & Instrumentation •Perform testing of In-process, Intermediates, Raw Materials (RM), Packing Materials (PM), Finished Products, Stability samples, and other analytical samples using wet chemistry, HPLC, and GC techniques. •Perform daily verification and routine calibration of instruments such as balances, pH meters, and maintain related records as per SOPs.

1. LIMS and Record Management

- Ensure online reporting of test results and timely entries in logbooks and LIMS (Caliber) for all analytical and calibration activities. •Maintain incoming material entries in respective registers and ensure records are in compliance with GDP.

1. Documentation & Specification Management

- Prepare and review specifications, Standard Test Procedures (STPs) and Standard Operating Procedures (SOPs) and Product General information for compliance with regulatory and pharmacopoeial requirements (e.g., USP, Ph. Eur.). •Maintain updated documentation with controlled status, ensuring prompt replacement of superseded versions in line with QMS.

1. Investigation & Deviation Handling

- Participate in the investigation of deviations, Out of Specification (OOS), Out of Alert Limit (OOAL), and laboratory incidents. •Initiate deviations for observed non-conformities and ensure accurate documentation, root cause analysis, and timely closure. •Implement and monitor the effectiveness of Corrective and Preventive Actions (CAPA) related to lab investigations.

1. Audits & Regulatory Readiness





- Represent QC during internal, customer, and regulatory audits (e.g., USFDA, WHO). •Maintain QC operations in audit-ready condition through routine self-inspections and readiness checks. •Address audit observations through effective investigation, CAPA execution, and implementation of continuous improvement.

1. Laboratory Safety & Housekeeping

- Ensure strict adherence to laboratory safety protocols, including proper PPE usage and hazard communication. •Oversee and maintain daily housekeeping and lab cleanliness to meet GMP and safety standards.

Preferred candidate profile

- M.Sc.(Chemistry)/B. Pharma. / M.Pharm. or equivalent qualification.
- 3 7 years of relevant experience in API Quality Control Laboratory in a USFDA/EU-approved pharmaceutical manufacturing facility.

Key Competencies

- The role requires robust technical and analytical knowledge of API testing, wet chemistry, HPLC, and GC, along with proficiency in laboratory instruments, calibration, and verification. Good understanding of GMP, GDP, data integrity (ALCOA+), regulatory requirements, pharmacopoeial standards, and documentation management is essential. The position also requires working knowledge of LIMS (Caliber), the ability to handle OOS, deviations, root cause analysis, and CAPA, as well as strong problem-solving, attention to detail, communication, and teamwork skills. A commitment to quality, regulatory compliance, laboratory safety, and continuous improvement is essential.

📌 Officer To Executive Analyst Quality Control-Peptide API Raks Dahej
🏢 Raks Pharma(A div. of Amneal Pharmaceuticals
📍 Dahej