Executive, Site Support
ConfidentialMumbai, India6 days ago
Job descriptionBMR & BPR ( Documents ) , working in shop floor , solid dose knowledge , softwarre- QMS Trackwise ,SAP LIMS ,Knoledge of how to handle change control ,Validation. Generation of Metrics for weekly CAPA metrics, weekly SOD (SOP's ) metrics, monthly SOD metrics, Bi- weekly Prod / Pkg training gap report summary, monthly training metrics report summary, monthly training metrics report summary – full report, CD metrics. Perform the work related to manufacturing SOD's such as issuing SOD E-Copies, issuing SAP training BET, execution of SOD's by accepting changes, formatting changes and completing rendition check, routing in Content Server, BET creation in SAP, generation of doc status report, periodic review of SOD, dispatch date and effective date tasks, effective date tasks- form updates. Accountable to ensure the submission of SOD E-Copies to the counterpart in a timely manner Perform all work in compliance with current SODs and GMPs. Ensure compliance with current Standard Operating Procedures and Work Instructions related to Document Specialist activities and report errors and inconsistencies associated with approved procedures to the Team leader. Develop and maintain effective working relationships with internal and external customers. Works as a member of a team to achieve all outcomes. Performs all work in support of our Corporate Values of Courage, Passion, Perseverance and collaboration; Demonstrates strong and visible support of our values. Performs all work in accordance with all established regulatory and compliance and safety requirements. 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. Education Bachelor's / Master's degree in Science / Pharmacy Knowledge, Skills and Abilities : Should be proficient in MS office tools. Should have excellent verbal & written communication skills. Experience of working on online modules / software would be an added advantage. Working knowledge of a document management system required. Ability to be flexible and multi-task in a rapidly changing environment. Experience Minimum 3-4 years of experience in the Pharmaceutical industry.
About Apotex Inc.
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
For more information visit : www.apotex.com .
Job Summary
- Responsible for creating and / or making formatting changes and edits to SOD draft documents based on supporting documentation from Business Units.
- Responsible to escalate any critical issues arising from SOD E-Copies while drafting and metrics generation.
Job Responsibilities
Job Requirements
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex 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.
Skills Required
trackwise , Lims, Qms, Sap, Document Management System, Ms Office
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Support Executive • Mumbai, India
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