Junior Team Member - QC

Division

Department

Sub Department 1

Job Purpose

Perform sampling, execute and document the analysis of raw materials, packing materials, products assigned for testing and complete all the stability studies in order to ensure its compliance to the laid down quality parameters and predefined specifications / standards and meet SRB targets

Key Accountabilities (1 / 6)

Analyse the assigned samples and chromatographic tests for analysis by using the suitable valid procedure and calibrated instruments to ensure the compliance to the set specification / standards

• Perform analysis for release of RM, PM, FP & water analysis and process / cleaning validation as per commitment dates
• Perform analysis for stability samples without any errors as per schedule
• Check the results of the tests performed, evaluate them against the specifications
• Review the TDS printed through LIMS for its completion before release

Key Accountabilities (2 / 6)

Perform all activities as per current standard procedures by referring to all approved procedures / specifications to ensure compliance to GLP and safety norms

Key Accountabilities (3 / 6)

Document all activities performed as per valid procedure online by using standard / approved formats or templates to ensure that all entries done are correct, accurate and authentic

Key Accountabilities (4 / 6)

Maintain and upkeep the laboratory working area by disposing off all analysed solutions and samples after review as per valid disposal procedures to ensure compliance to GLP

Key Accountabilities (5 / 6)

Provide suggestions and ideas by exploring new possibilities to achieve cost saving and work simplification

Key Accountabilities (6 / 6)

Major Challenges

Key Interactions (1 / 2)

Key Interactions (2 / 2)

Service Engineer to resolve instrument related issues, breakdown (Need Basis)

Dimensions (1 / 2)

Non-conformance rate should be below 1.5%

Dimensions (2 / 2)

Key Decisions (1 / 2)

Procurement of required instruments and glassware standards to Team Leader (Routine / Stability)

Key Decisions (2 / 2)

Education Qualification

B. Sc. (Chemistry) or B. Pharm.

Relevant Work Experience

0-3 years of experience in quality control function of a pharmaceutical organisation

Skills Required

Validation, Lims, Calibration, Qualification