Job Description

Job Purpose

The incumbent is responsible for the receipt and storage of intermediate products, final products, raw materials and stability samples in accordance with procedures as well as issuance of documentation, and procurement of laboratory consumables and equipment.

Key Accountabilities

Accountability Cluster

Quality Control Systems

• Issuance of documents for Finished product, Stability, Packaging, Micro and Raw material.
• Initiation of required changes as per change control.
• Good Laboratory Practice and Safety

Good Laboratory Practice and Safety

• To ensure compliance with current Good Laboratory Practices as laid down in the Quality Control procedures.
• Maintenance or upkeep of Laboratory working area i.e. good housekeeping.
• Following the laboratory laid down safety precautions while working in the laboratory.
• Maintenance of personal protective equipment and adherence to safety measures in the laboratory.
• Responsible for coordinating the removal of waste (including microbiology waste) from the QC lab timeously.

Administrative (Lab Support)

• Responsible for ensuring all SOP I WI Index in all files in QC are current.
• Preparation and review of documents including specifications, SOP/ WI etc.
• Circulation of draft documents to subject matter experts for review, correction and finalization of the documents based on comments.
• Receiving and confirming all samples received into the Lab.
• Ensure control and issue of relevant documentation i.e. issue specifications and methods to relevant raw materials/products
• Archiving and retrieval of documents.
• General administrative duties including photocopying, faxing, filing, binding, and scanning of relevant documents onto SharePoint.
• Ordering and fetching of stationery used in the lab.
• Co-ordinate activities involved with procuring goods and services such as price, availability, and delivery schedule.
• Obtaining the most cost-effective quotes from suppliers/agents, ordering and control of stock for IPCI management of HPLC and GC columns
• Uploading of invoices on the CIMMRA portal.
• Negotiating prices or contracts within limitations and scope of authority and preparing purchase requisitions on SAP.
• Receiving and sorting consumables and lab equipment according to their respective storage areas
• Preparing all the documents and information such as receipts, and GRN's delivery notes required to process payment according to the stipulated payment term.
• Ordering of primary standards and ensuring receipt and storage conditions of the same. Liaising with Cipla India, courier and customs for standards.
• Control, receipt, dispensing, and issuing of standards including but not limited to Primary, calibration, and working standards.
• Dispense of standards.
• management of placebos drawing up protocols for placebos, protocols for qualification documents for standards, validity study for standards control and maintenance of poisonous chemicals purchase, and review of compendia.
• Filing of QC documentation.
• Preparation of a list of persons who should attend the training and list down the names who have not attended the training. Ensuring all work requests are raised timeously.
• Maintenance of stock levels for laboratory consumables.
• Any other assignment allocated by QA Lab Compliance Supervisor

Skills & Knowledge

Educational Qualifications

National Diploma in Biotechnology or equivalent qualification

Advanced Diploma in Biotechnology

Relevant Experience

1-2 years in an internationalized/accredited pharmaceutical production environment