Team Member Quality Operations

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

• Gather all the samples for analysis by checking the consignment for sampling


• Gather the essentials like standards, glassware, solvents to perform the analysis as per specification


• Operate the instruments and perform routine/stability as per SOP 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

• Maintain system integrity by updating documentations and deviations on CipDox while performing operations


• Maintain all the online documentation and timely entries and supporting documents


• Prepare new documents and update existing documents as per GMP requirement

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        

• Maintain equipment, facility and block premises as per SOP


• Perform validation, qualification and calibration as per schedule and update output of all activities in the systems

Key Accountabilities (5/6)

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

• Conduct operational studies to find improvement areas and implement new development projects


• Strive for continuous automation of processes through implementation of new processes

Key Accountabilities (6/6)

Major Challenges

• Delay in performing analysis or re-planning due to frequent changes in production plans. Overcome by conducting performance dialogues and handshakes meetings identifying priorities


• Delay in performing laboratory activity due to instrument breakdown. Overcome by ensuring timely availability of parts and engineers


• Delay in releasing the batches due to non-availability of standards, glassware, chemicals. Overcome by coordinating with CFTs and escalations

Key Interactions (1/2)

• Unit Planning for daily release of RM,PM and FP (Daily)


• Site QC (Non-Routine) for essentials of analysis (Daily)


• CDC for specification changes implementation (Need Basis)


• Unit QA for non-conformances (Need Basis)


• Stores for inventory (Daily)

Key Interactions (2/2)

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

Dimensions (1/2)

• Number of FP batches released: 3-4


• Number of RM analysis conducted : 3-4


• Number of studies conducted for Stability samples : 10


• Non-conformance OOS/OOT to be closed within 7 working days


• Non-conformance rate should be below 1.5%

Dimensions (2/2)

Key Decisions (1/2)

• Suggestions for improvement of QC productivity to Team Leader (Routine/Stability)


• 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