Senior Officer QualityAssr-ARPL-QAIP AR

ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery, development and provision of new medicines to help improve the quality of life of patients with debilitating and life-threatening diseases. Investigation into the pathological role of iron in human disease, and how to use novel medicines to treat conditions created or worsened by iron, is a major research focus of ApoPharma.

Job Summary

IPQA activities

Job Responsibilities

• Line clearance of various in process stage such as dispensing, granulation, compression, coating, sampling.
• Routine monitoring of all functional area to ensure adherence to the SOPs.
• Preparation and review of standard operating procedure.
• Performing in-process checks during manufacturing.
• Performing of AQL, collection of samples as applicable and trending of AQL.
• Sampling of SLED batches hold time study sample, in-process samples/finished product samples.
• Collection, storage, and disposal of reserve sample.
• Review of executed batch records and logbooks.
• Co-ordination for process validation and cleaning validation execution.
• Preparation for internal, customers & regulatory audits and making the compliance for the same.
• Coordination for internal, customers & regulatory audit compliance work.
• Works as a member of a team to achieve all outcomes.
• To perform swab/rinse sampling for the cleaning verification and validation programme, cleaning and verification of sampling thief’s and accessories.
• Create a culture which values trust and provides the opportunity for employee development and growth in pursuit of our purpose and demonstrating our core values – Collaboration, Courage, Perseverance and Passion.
• All other duties as assigned.
  
  

• Education
• Bachelor of Pharmacy/ Science or any equivalent degree.

• Knowledge, Skills and Abilities:
• Should possess good communication and interpersonal skills along with computer efficacy in MS-Office and internet.
• Preparation, review of protocol & reports.

• Experience:
• Minimum 2 Years of experience in GMP regulated pharmaceutical industry.