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

Coordinate with concerned department for monitoring /tracking of change control for its effective implementation and clouser of Change controlin an timely manner.

Job Responsibilities Review of the MBPCR's and MGCR'sfollowed by change control impact assessment pror to approval. Review of the excuted BPCR's /GCR's and Manufactiring related documentation support. To insure manufacturing documents are issued/archived as per procedure in line with manufacturing activities. To monitor and ensure the Dispatch activities initiated after the Quality release. To coordinate with the manufacturing team to address any Quality issues arises during manufacturing. To support for addressing Deviation,lnvestigation and Change control change control activity. Equipment and area clearance certification for product changeover. To perform the SAP related activities. Handling of Deviation /CAPA related to manufacturing. Preparation and review of the Protocol and report, monitoring of the Process and cleaning validation activities. Preparation and review of cleaning evaluation report. Preparation and review of annual Product Quality Review(APQR). Preparation and revision of the Departmental SOP ,Form and Annexures. Monitoring of the cGMP compliance through Plant rounds To adhere the EHS policy & procedure in routine activities. To involve in EHS related activities on need basis. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education M.Sc./ M. Pharma Experience 6-10 year experience, with demonstrated skill in preparation of protocol and reports, monitoring of process validation, etc.

 

At ApoPharma, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. ApoPharma offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.