Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, iversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.
Post: HEAD QA - ANSC-12000002MK
Primary Function / Primary Goals/Objectives
The QA Organization in India ANI Supply Chain is responsible to support the operations and business growth at the India AN commercial office. The principle responsibility is to ensure quality and compliance of Abbott Nutrition products distributed in India as well as those manufactured at third party manufacturing facilities in India. The focus of this position is to lead the QA team to support new production introduction in India and responsible for specific TPM facilities, this includes responsibility to assess, establish and improve operations as required to maintain optimum performance and adherence to Abbott Nutrition quality standards.
• Work with project management on global/local nutritional project teams as assigned, to identify key quality issues related to design, manufacturing and product start-ups and support product launches in country.
• Provides leadership in Quality Assurance at India commercial and TPM operations. Responsible for overall QA decision at the affiliates' management.
• Lead and manage a team of in country QA subject matter experts in project management, new production introduction, TPM operations and QA Compliance to ensure high quality and compliance product release to marketplace.
• Assure active and effective communications between commercial and division functions regarding quality issues.
• Ensure quality and compliance of Abbott products manufactured at TPM facilities. This involves day to day management of quality system requirement for TPM assigned.
• Directs activities in support of division and corporate quality initiatives. Provides guidance in the implementation of the requirements to ensure business alignment in country.
• Utilize understanding of QA systems and problem solving tools to provide alternative solutions to quality issues.
• Support disposition of product batches, utilizing CAPA tools to facilitate investigations, troubleshoot and resolve quality issues.
• Accountable for complaint management in commercial operations.
• Accountable and responsible for affiliate and India TPM preparation for Division and Corporate audits and management of audit corrective action plans.
• Accountable for establishing and maintaining the training of Abbott Quality Systems in commercial operations.
• Accountable and responsible for the vendor program at the TPM. Work with suppliers and TPM to resolve issues.
Reports: 3 to 6 exempt and non exempt staff.
Bachelor’s degree in a relevant biological or technical discipline is required (Chemistry, Microbiology, Food Science, and Engineering). Masters degree in science or business is preferred, but not required.
Ten or more years in a regulated pharmaceutical or nutritional food-manufacturing environment, preferably pediatric and medical nutrition products, in a Quality, R&D, Operations function and good knowledge of food cGMP and nutritional regulations is necessary. Incumbent should possess three to five years managerial experience with good demonstration of leadership skills in people management, talent development and cross functional coordination in project management. Success will depend on good problem solving abilities and strong QA knowledge in nutritional or pharmaceutical manufacturing controls and quality systems. Experience establishing diversified team operations in a manufacturing or commercial setting would be highly desirable.
This position will independently interface with Abbott affiliates and TPM’s. Success will depend
on leadership in identifying and correcting quality issues through effective communication, and strong interpersonal and presentation skills. Issues will typically involve GMP’s, formulation, process control, fitness for use criteria for risk assessment using strong decision-making and problem solving skills.
Quality issues can have significant adverse affect on Abbott customer confidence, worldwide image and the performance of Abbott stock. The position requires independent work and effective communication with key individuals within Abbott. It requires the capability of making recommendations in the best interest of Abbott Nutrition, without compromising quality.
Experience: 10 or more years exp
Location: Mumbai- Maharashtra
Industry Type: Pharma / Biotech / Clinical Research
Functional Area: QA
Last Date: 8th March, 2013
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