Zydus Hospira Oncology Pvt. Ltd.

Transcription

1 Company, Position & Person Profile Zydus Hospira Oncology Pvt. Ltd. 6/7/15

2 About Zydus Hospira Oncology Pvt. Ltd. Zydus Hospira Oncology Private Limited (ZHOPL) is a joint venture company in Ahmedabad, India jointly owned by Cadila Health Care Limited, a company incorporated under the Indian Companies Act, 1956 and Hospira, Inc., a company incorporated under the laws of the State of Delaware, USA. ZHOPL manufactures oncology drug products that is marketed, sold and used throughout the world. ZHOPL was set up in 2005 as a JV between Cadila Health Care (Zydus Cadila) and Mayne Pharma Ltd, Australia (Mayne Pharma was acquired by Hospira Inc.,USA in February 2007 hence this company is since known as Zydus Hospira). Cadila Healthcare has the expertise in handling a wide variety of finished dosage forms of pharmaceutical drug products and has the ability to establish and operate pharmaceutical projects of world-class standards and secure regulatory approvals from global regulatory bodies, such as the United States Food and Drug Administration, MHRA. Hospira, Inc. is a global speciality pharmaceutical and medication delivery company that develops, manufactures and markets healthcare products that help improve the safety, efficacy and costs of patient care.hospira s portfolio of products and services includes speciality injectable pharmaceuticals, medication delivery systems, injectable pharmaceutical custom manufacturing services and other products, including critical care devices. Vision To be Hospira s Preferred Manufacturer for oncology products and become a centre of excellence. To be no 1 Cytotoxic Manufacturer in India for global markets and increase penetration from 24 to 59 markets across the globe by 2015

3 Zydus Hospira Oncology Pvt. Ltd.. State-of-the-art Manufacturing Plants

4 THE POSITION Organization Zydys Hospira Oncology Pvt. Ltd. Title Deputy Manager-Quality Compliance Location Pharmez SEZ,Ahmedabad. Job Summary To ensure analytical compliance Reports To Deputy General Manager-Quality Assurance Direct Reports Officers, Executives-Quality assurance Key Stakeholder All departments of ZHOPL Key Skills Compliance Cell

5 Deputy Manager-Quality Compliance Deputy Manager-Quality compliance shall be responsible for ensuring and timely completion of analytical compliance at ZHOPL. Pre-requisite: Essential Qualification: M.Sc/ B. Pharm Total Number of years of experience: 6-8 years and above in analytical compliance in Quality assurance or Quality Control-Chemistry department at manufacturing sites supplying to US, Europe markets. Must have a sound knowledge of cgmp requirements from Quality compliance perspective. Preferred Age Group: Between years Key Responsibilities:. To prepare and review SOPs for Q.A department. To compile the data and to prepare Annual Product Quality Review. Review and approval (where required) of the Standard Operating Procedures of the plant. To review and approve the change control, deviation, Corrective and Preventive action report, Effectiveness Plan, Hold Notice, Critical Work order, Breakdown Intimation slip, out of specification, update the log and maintain the reports for the same. To review and control the quality documents like Master Production and Control Record, Master packing Records, Specifications, test procedures etc. of the plant. To review all Change control, Deviation, CAPA, EP etc. pertaining to Quality Control lab. To perform Internal Audit, mainly of Quality control department.

6 To perform GAP assessment of all practices of Quality Department. To maintain the log for technology transfer documents, completed documents & records. To prepare the schedule and vendor list for vendor qualification. To prepare schedule for internal audit and to coordinate, conduct and close the observations after appropriate corrective actions. Documenting the change controls and ensuring the process during break down and other critical condition and documenting the same. To select the batches and collect the samples for stability study for the respective product manufactured. Handling the product complaint and immediately responding to the Head Quality/ QA Manager on receipt of the complaint. To ensure the stability management as per SOP and regulatory requirements. To receive, distribute and maintenance at site and printer s end art works of printed packaging materials as per the SOP and regulatory requirements. To review the test reports of materials and products, calibration report, by reviewing chromatograms, audit trails, logbooks, data generated through instruments, calculations, trend reports etc. To complete the assessment of New Product Introduction as per SOP To update the compliance to compendia as and when new bulletin from external partner/ compendia received To ensure availability of updated Approved Vendor List. Review and monitoring of suppliers of materials. Zydus Hospira Oncology Pvt. Ltd. s Mission and values. Mission To be customer centric organization with the best Quality, Cost and Service Values Integrity and Transparency Quality Culture Management mindset: Quality is not expensive it is priceless Respect and understanding

7 We Hire the Best. We attract top talent because of ZHOPL s reputation as a great company for leaders, and we identify the best applicants by using a proven recruiting process that measures intelligence, assesses character and leadership, and predicts success at ZHOPL. Zydus Neev: The Leadership Competency Framework

8 The Person Hands-on expertise of handling analytical compliance and Regulatory requirements independently, and handling complexities arising in the process. Should have worked Quality Control-Analytical Compliance in regulated plants having approvals of US FDA, MHRA. etc. Experience Hands-on experience in successfully handling and implementing cgmp (Current Good Manufacturing Practice). Working closely with Quality & Regulatory functions to create a highly compliant environment. Must have sound knowledge handling regulatory and analytical compliance. Strongly demonstrated success in capacity enhancement initiatives in solving issues in Compliance related activities. Bring a sense of urgency to situations, demonstrate an active approach, be willing to get involved in order to increase the pace and achieve goals and objectives. Interview Process Zydus Hospira Oncology Pvt. Ltd. uses benchmark HR practices and is known for employee centricity and well-being. We deploy scientific and objective methodologies like psychometric tools, in-house Assessment Centres, one-on-one discussions with our leaders panel while taking people aboard. Good Luck!!!