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Job as Quality Assurance Manager Analytical in Abbott India


Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, diversified 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: Quality Assurance Manager Analytical

Job Description:
he position holder accomplishes his job with the help of following team memebers
Sr QA Executives : 2
QA Officers: 18
And Workman in Analytical lab

Job holder is Accountable & responsible for providing complete support to manufacturing, engineering, procurement etc and ensure product manufactured is right first time pertaining to analytical parmaeter.
The position oversee the responsibility of Incoming ingradient quality and packaged product quality.

Key Responsibilities:
Operations
• To execute physical, analytical and sensory checks on all the raw materials & finished products as per the laid down procedures & provide feed back on deviations, if any, to the concerned functions like Manufacturing, Purchase etc., for corrective actions
• The Manager, Analytical Laboratory of Abbott Jhagadia plant is responsible for managing the overall operations in the analytical lab to assure the validity of all testing data, and to assure the compliance with relevant Indian regulations/standards and company policies/standards.
• Establishing and reviewing below site analytical lab processes and methods with the support of global project team and functional head, based on the relevant Indian regulations/standards and company policies/standards.
• Implementing, maintaining and improving the established analytical lab and in-process testing processes and methods. Preparing and/or reviewing analytical associated protocols/procedures once any updates, Reviewing executed documents associated with analytical testing, Monitoring, communicating internal and external analytical testing associated trends and recommending compliance actions, Monitoring, analyzing and communicating site analytical testing results and productivity, and recommending improvement actions, Monitoring, analyzing and communicating site analytical testing associated deviations/findings and recommending CAPAs. Participating site internal audits on cleaning validation and recommending CAPAs. Providing professional analytical inputs when any needs from other functions, such as supplier evaluation, validation, ect.
• Managing the analytical lab to assure the EHS compliance, Maintain safe and healthy working conditions for employees under his/her supervision. Promote EHS awareness to subordinates, Attend EHS training assigned and ensure that employees who report to him/her attend required training. Encourage employees under his/her supervision to submit Near Miss reports and other opportunities to improve the EHS Program. Instruct employees under his/her supervision in use of PPE in accordance with all safety rules and practices.
• Analytical laboratory equipment maintainence and calibration, Analytical reagents, reference standards and glassware procurement and management
• Carryout cleaning validations for new equipment and existing equipment and suggest effective methods of cleaning for ensuring right product quality, Support the validation activities in terms of design, operational and performance qualification of the process and laboratory equipment

Cost
• To support in preparation of Opex & Capex budgets for Analytical function, making the proposal and close follow-up of execution of new and exisitng projects

People
• Building and Managing analytical team to assure the capability and stability, Recommending the structure, roles and responsibilities for the analytical lab, Recruinting talents, Behaving as an example of the analytical staff, Communicating the site goals/metrics, Performing people manager’s activities on setting goals, coaching and reviewing performance, Supporting functional head on building the function structure to achive the function goals
• Conduct annual performance reviews with all direct reports. Manage performance development plans for all employees in the department. Conduct quarterly updates on goals and accomplishments.
• Assure all required training is provided and completed by all departmental employees, Maintain and improve job descriptions of all positions within the department.
• Promote and support team development activities
• Impart training to workmen and staff on GMP requirements and QMS requirements
• Draft Micromanual, develop micro quality plan for the new site in line Abbots International Quality plan

Compliance
• Carryout stability studies for all the products manufactured as per the ANI quality policy & procedure requirements
• Implement BIS method where applicable
• Preparation of SOPs and work instructions whenever new QMS requirements become effective. Carryout gap analysis of new QMS documents and take actions for their implementation
• Ensure that the laboratory operates with calibrated equipment and carryout performance qualifications of the equipment, as per the frequencies
• Meet the requirements of EHS/GPCP in handling of Biohazardous waste generated at the laboratory
• To ensure the Analytical compliance of ISO 17025, ISO 9001, ISO 22000 and HACCP, BIS, FSSA requirements in and around the manufacturing facility by regular interaction with all stakeholders
• Ensure all the requirements as per the ISO 9000:2000 / QMS elements and implementing the updated requirements in Quality Assurance to improve & sustain the systems

Key Behavioural Competencies Required: Adaptability, Innovation, Initiative, Teamwork, Integrity
• Interpersonal skills in order to have healthy relationship with colleagues working in different functions at site.
• Decision making skills regarding the Analytical quality status of finished products, in-process materials & environment and Hygiene/GMP of process equipments, manufacturing area/ware house/Factory premises. & dispatch vehicles ex Jhagadia plant.
• Communication skills in order to understand and provide necessary feedback or solutions within the QA team and internal customers.
• Analytical thinking in order to go in depth understanding of RCA of Quality & Hygiene/GMP related complex issues and provide the best feasible solutions at shop floor.
• Decision making skills in order to handle the Analytical quality problems involved at Site

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