Assistant Manager – Quality Assurance | Abbott | Jhagadia

Job Description

Primary Functions/Goals/Objectives:

  • Lab operations management, Review and Release of Raw Materials & FP as per SLA
  • Ensure GMP/GLP, EHS compliance, Internal/external Audit compliance, and team & lab budget management.

Major Responsibilities:

  • Demonstrate Interpersonal skills and maintain a healthy relationship with cross-functional team members at the site.
  • Decision-making skills regarding the Analytical/microbial quality status of Raw materials & environment and Hygiene/GMP of process equipment, manufacturing area/ware house/Factory premises.
  • Sound communication skills in order to understand and provide necessary feedback or solutions to 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 on the shop floor.
  • Decision-making skills in order to handle the Analytical/microbial quality problems involved at the Site.
  • Good Anticipation skills for identifying pre signals & roll out the mitigation plan to overcome quality/ safety events.
  • Good hands-on experience in wet Lab analysis, Chromatography techniques (HPLC, ICPMS, LCMS) & breakdown troubleshooting experience.

Accountability/Scope:

Primary Function:

Operations
  • Ensure the right product quality is released to the market by carrying out the timely and accurate analysis of all the finished products in shifts and timely feedback (signals) to Production on quality trends.
  • To review physical, analytical, and sensory reports of raw materials & finished products as per the laid down procedures & provide feedback on deviations, if any, to the concerned functions like Manufacturing, Purchase, etc., for corrective actions
  • Good hands-on experience in wet Lab analysis, Chromatography techniques (HPLC, ICPMS, LCMS) & breakdown troubleshooting experience.
  • Shifts planning and smooth operation of labs.
  • Budget management & take cost-saving initiatives.
  • 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 compliance with relevant Indian regulations/standards and company policies/standards.
  • Establishing and reviewing below site analytical lab processes and methods with the support of the 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 in site internal audits on cleaning validation and recommending CAPAs. Providing professional analytical inputs when any needs from other functions, such as supplier evaluation, validation, etc.
  • Managing the analytical lab to assure EHS compliance, and Maintaining 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 the use of PPE in accordance with all safety rules and practices.
  • Analytical laboratory equipment maintenance 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 the 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 the preparation of Opex & Capex budgets for Analytical function, making the proposal and  close follow-up of execution of new and existing projects
People
  • Building and Managing the analytical team to assure the capability and stability,  Recommending the structure, roles, and responsibilities for the analytical  lab,  Recruiting 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 achieve the function goals
  • Promote and support team development activities
  • Impart training to workmen and staff on GMP requirements and QMS requirements

Compliance
  • Implement the 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 carry out performance qualifications of the equipment, as per the frequencies
  • Meet the requirements of EHS/GPCP in the handling of Biohazardous waste generated at the laboratory
  • To support the Analytical compliance of ISO 17025, ISO 9001, ISO 22000, and HACCP, BIS, and 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 implement the updated requirements in Quality Assurance to improve & sustain the systems.

Desired Candidate Profile:

Education:
  • M.Sc. / M. Tech in Chemistry (Dairy / Food) with minimum 8-12 years of relevant experience
  • Thorough knowledge of general Analytical analysis procedures & Team management.
  • Sound knowledge of Analytical &/ Microbial lab operations for dairy/food/pharma or nutrition industries.
  • Understanding of Quality systems ISO 9001/ISO 22000/ FSSA /BIS / Risk Assessment and exposure for HAZOP/HACCP analysis.
  • Good communication & decision-making skills
Background:
  • 8-12 Years of experience in the reputed Food/ Nutrition / pharmaceutical industry.
  • Ability to accurately interpret the quality-related problems of ingredients finished food & process checks in food processing.
  • Ability to conduct troubleshooting studies to resolve the problems encountered w r t Quality and Hygiene/GMP at Site
  • Ability to handle all types of Analytical/ microbial quality issues in the entire supply chain.
  • Good knowledge of quality tools.
  • Good hands-on experience in wet Lab analysis, Chromatography techniques (HPLC, ICPMS, LCMS) & breakdown troubleshooting experience.

Location