QC Analyst-Chemistry job at Abacus Parenteral Drugs Limited

Background

Abacus Parenteral Drugs Limited is looking for passionate, skilled, and motivated professionals to join our dynamic team across multiple departments.

Position Purpose

To ensure effective and timely testing of all samples in accordance with requirements and in line with fast and changing quality procedures and principles, prioritization of testing, management of resources, and effective communication at all levels are necessary.

Qualifications and Requirements

• BSc Chemistry or equivalent degree
• Experience in a pharmaceutical/healthcare industry is an advantage

Training Requirements

• Basic safety and GMP training

• To adhere to procedures on cGMP and GLP and relevant ISO procedures that guide all QC processes.
• Conduct quality control tests on water, bulk, raw material stability samples, and finished products.
• Document and prepare reports for all Q.C. activities performed online; calibrate and maintain laboratory equipment as per the plan.
• Interpret all documents in QC process and revise and prepare SOPs and COAs as required in the process
• Work effectively with other analysts and team leaders to achieve shared goals and meet timelines for batch processing and filling processes.
• Participate in OOS, OOT investigation, deviation handling, change control, CAPA closure, and quality risk management for continuous improvement.
• Participate in training, knowledge sharing, and transfer activities for efficiency and competency.
• Sampling of RM, FP, preparation of reagent & standardization of reagent per production plan requirements.
• Calibration of glassware of new glassware’s.
• Working standard preparation.
• Handling & maintaining reference standards as per reference standard SOPs, preparation of working standard.
• Perform analysis for intermediate sample, finished product sample, Raw material sample, stability sample, PPM & SPM as per work plan ensure it will meet with specifications.
• Perform method validation & verification for new method and establish specifications.
• Proper use and handling of chemicals and consumables
• Perform online reporting & keep records.
• Timely and proper communication with staff at all levels while making critical escalation on time.
• Use provided personal protective gears appropriately.
• Proper communication and handling and investigation of all incidences, near misses and accidents

• Excellent report writing skills
• Analytical skills
• Communication skills
• Interpersonal skills
• Computer skills
• Able to learn and adapt to change
• Innovative/creative skills
• Problem-solving skills
• Respect for others
• Teamwork
• Responsibility

• BSc Chemistry or equivalent degree
• Experience in a pharmaceutical/healthcare industry is an advantage