Walk-in || Production Executive R&D And QC

Rampex Labs Roles & Responsibilities

For recruitment purposes, below are the key roles, responsibilities, and skills for Production, Quality Control (QC), Quality Assurance (QA), and Research & Development (R&D) in an API pharmaceutical manufacturing company.

1. Production Department API

Roles and Responsibilities

• Execute API and intermediate manufacturing as per Batch Manufacturing Records (BMRs).
• Operate reactors, centrifuges, ANFDs, dryers, and filtration equipment.
• Perform charging, reactions, extraction, filtration, drying, and material transfer operations.
• Monitor process parameters such as temperature, pressure, pH, and reaction time.
• Follow GMP, SOPs, safety procedures, and housekeeping standards.
• Maintain batch records and equipment usage logs.
• Coordinate with QC and QA for sampling, testing, and batch clearance.

Key Skills: API manufacturing, reactor operations, process equipment handling, BMR documentation, GMP and safety compliance.

2. Quality Control (QC) Department

Roles and Responsibilities

• Analyze raw materials, intermediates, in-process samples, and finished APIs.
• Operate and maintain analytical instruments such as HPLC, GC, KF, and UV.
• Perform testing for assay, impurities, residual solvents, moisture, and other specifications as applicable.
• Prepare reagents, volumetric solutions, and reference standards.
• Review analytical data and maintain laboratory records.
• Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results as per procedures.
• Ensure compliance with pharmacopoeial standards, GMP, and laboratory SOPs.

Key Skills: HPLC, GC, analytical chemistry, wet analysis, method validation, OOS investigation and documentation.

3. Quality Assurance (QA) Department

Roles and Responsibilities

• Review Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs).
• Ensure compliance with cGMP, SOPs, and regulatory requirements.
• Manage deviations, CAPA, change controls, and investigations.
• Perform documentation review and support batch release activities.
• Conduct internal audits, vendor qualification, and employee training.
• Coordinate process validation, cleaning validation, and quality risk assessments.
• Ensure data integrity and maintain quality management system (QMS) records.
  API & Intermediates Manufacturer India+1

Key Skills: cGMP, QMS, BMR/BPR review, deviations, CAPA, change control, audits, validation and documentation.

4. Research & Development (R&D) Department – API

Roles and Responsibilities

• Develop and optimize synthetic routes for APIs and pharmaceutical intermediates.
• Perform laboratory experiments, chemical reactions, and process development studies.
• Optimize reaction parameters, yield, purity, and process efficiency.
• Conduct reaction monitoring using TLC, HPLC, GC, or other suitable analytical techniques.
• Perform process scale-up from laboratory to pilot or manufacturing scale.
• Prepare experimental records, technical reports, and process development documents.
• Coordinate with Production and QC for technology transfer, troubleshooting, and process improvement.

Key Skills: Organic chemistry, synthetic chemistry, process development, reaction optimization, purification techniques, analytical data interpretation and laboratory safety.Role & responsibilities

Preferred candidate profile