Senior Executive, Quality Control

3 days ago

Bengaluru India Apotex Inc. Full time

Job Description About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Regular review of Raw material, packing material, Water Analysis, In-process samples, cleaning validations, finished products,analytical method validation, calibration and exhibit & stability samples. Job Responsibilities - Review of Raw material/ Packing material/ Water Analysis / In-process/Semi-finished / finished product / Validation Samples/Hold time study samples / stability Samples /Analytical method validation , Technology Transfer samples , calibrations and any other samples in Quality control laboratory. - To be responsible for all activities in the quality control Laboratory, including cGLP, documentation and implementation of departmental quality systems. - Supporting for closing of investigations and giving training for respective investigation wherever required as per procedure. - To provide technical review support to Apotex group of companies during activities like technology transfer by assisting Senior Executive/Assistant manager/Deputy Manager. - To generate documents and maintain records and required trending ,training related to laboratory activities. - Performs all work in accordance with all established regulatory, compliance and safety requirements. - Perform all work in support of our Corporate Values and Demonstrates strong and visible support of our values. - Perform all other duties as assigned by Head of the DepartmentDesignee. - Works in a safe manner , collaborating as a team member to achieve all outcomes. - 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 - Minimum MSc/B Pharma or any equivalent degree. - Knowledge, Skills and Abilities: - Data base Management system like Empower, LIMS, SAP & QMS. - Technical skill in reviewing Quality control data. - Maintaining Good interpersonal skills and communication skills. - Well expertised in cGDP and cGLP. - Experience - Minimum 5 to 9 year's experience in GMP regulated pharmaceutical industry. At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer 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.

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