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Assistant Manager - Micro & IQA Labs


Abbott


Location

Jhagadia | India


Job description

To manage Micro & IQA labs operations at Jhagadia site. In this role incumbant assess and assure the quality of RMs/PM released & product manufactured at the site meet AN & regulatory requirements.. Jobholder ensures the quality of major and minor ingradient, PM and specialised analysis of microingradients done at in-house labs. Also responsible for SENs, SCNs, RM/PMs incoming inspection & release, Budget & consumbles management of IQA & Microbiology labs. Job holder required to plan & coordinate work distribution in IQA & Microbiology labs, team development & management.

Responsibilities:

Operations

The Asst. Manager, IQA & Microbiology Laboratory of Abbott Jhagadia plant is responsible for managing the overall operations in the IQA & Microbiology labs to assure the validity of all testing data, and to assure the compliance with relevant Indian regulations/standards and company policies/standards.

* To execute Microbiological checks on all the raw materials, PM,Inprocess, EMP & finished products as per the laid down procedures & provide feed back on deviations, RCAs, if any, to the concerned functions like Manufacturing, Materials, SQA, Procurement, PQA etc., for corrective actions

* Coordination & collaboration with SQA team to streamline RMs/PM issues vs division guidelines compliance.

* Management of SENs (Supplier event notifications) & compliance to division guidelines.

* Management of SCN (Supplier change notifications) & Compliance to division guidelines.

* RMs specs, test methods & SAP gap assessment and streamline the process, address gaps if any.

* Art work & Packaging material specs, test methods & SAP gap assessment & streamlines gaps if any as per division guidelines.

* Review and tracking of SENs & RCAs from vendor and provide inputs for effective CAPA and avoid any repeat events from vendor.

* Review online signals & events coordinate with SQA and address the events/Signals as per AN guideline.

* Review and enhancement of packaging & IQA lab infrastructure & performance.

* Defect gallery alignment for PM and ensure online signals are addressed.

Establishing and reviewing below site IQA & Microbiology 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

Managing IQA & Microbiology 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.

IQA & Microbiology laboratory equipment maintainence and calibration, reagents, Micro positive and negative cultures 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 IQA & Micro Labs , making proposals and close follow-up of execution of new and exisitng projects and spend of the assigned budget as per agreed timelines.

People

Building and Managing IQA & Microbiology team to assure the capability and stability, Recommending the structure, roles and responsibilities for the IQA & Micro labs, Recruinting talents, Behaving as an example with 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, GLP and GDP requirements.

Motivate the team and gerate the idesa and implementation.

Compliance

Ensure IQA & Micro Labs are 24/7 audit ready and complying all AN/AQ policies/elements and Regulatory requirements.

* Carryout stability studies for all the products manufactured as per the ANI quality policy & procedure requirements

Implement AN & 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 Microbiological compliance of 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 QMS elements and implementing the updated requirements in Quality Assurance to improve & sustain the systems

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 Microbiological quality problems involved at Site

Education

M.Sc. Microbiology or Dairy Microbiology (Dairy / Food)

08 -12 years of experience in a reputed food processing industry with Microbiology operations & team management skills.

Background

Thorough knowledge of incoming RMs testing, general/pathogenic analysis procedures

Understanding of Quality systems ISO 22000/ FSSA /BIS / Risk Assessment and exposure for HACCP analysis

Ability to accurately interpret the quality related problems of ingredients, finished food & process checks in food processing.

Ability to conduct trouble shooting studies to resolve the problems encountered w.r.t Quality and Hygiene/GMP at Site

Ability to handle all type of Microbiological quality issues in the entire food chain

Scope

The Job Holder is responsible to Manage Microbiology & IQA laboratory functions and Support Abbott Nutrition Supply chain Jhagadia Operations.


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