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Officer - Quality Assurance

2 months ago

Jhagadia, India Abbott Laboratories Full time

**Primary Objective**:
Analysis and Review of IP, FP.

**Major Responsibilities**:
On time analysis & release of raw material, in process samples & finished product samples.
Ontime Training completion within predefined timelines.
Laboratory standards, chemicals preparation, standardization & stock management.
Lab SOP & work instruction review & revision.
Lab Equipment calibration & preventive maintenance.
Adhere Abbott safety & quality requirements.
Lab area 6S, GMP, GLP management
- Laboratory consumables stock management etc.

**Education**:
B.Sc/M.Sc. / M.Tech in Chemistry (Dairy / Food) with minimum 1-3 years of relavent experience.
Thorough knowledge of general Analytical analysis procedures.
Understanding of Quality systems ISO 9001/ISO 22000/ FSSA /BIS / Risk Assessment and exposure for HAZOP/HACCP analysis.

**Background**:1-3 years of experience in a reputed food processing / pharmaceutical industry. (Out of which at 1-2 years as QA Executive Analytical Laboratory in similar industry is preferrable)
- Being proficient in Gujarati is advantage.

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 Analytical quality issues in the entire supply chain.
- Hands on experience of analytical lab equipment operations. (i.e. HPLC, ICPMS, LCMS, Protein Analyser, Fat Analyser, moisture analyser etc.)

**Accountability & Scope**:
**_
Primary Function:_**

**_ Operations_**

Ensure right product quality is released to 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.
- Responsible for analysis of in-process liquid samples & finished product powder for macro & micro nutrients (protein, fat, moisture, minerals, vitamins etc).
- Responsible for operation, calibration & maintenance of equipments as per Abbott & OEM Guidelines.
- To maintain and upkeep the hygiene, cleanliness and work place safety in the lab.
- Laboratory SOP & Work instruction review & revision inline with global AN/AQ policies & other relevent governing documents (Including regulatory documents FSSAI,BIS etc.).
- Participate in product sensory analysis.
- Implementing, maintaining and improving the established analytical lab and in-process testing process and methods.
- Monitoring, analyzing and communicating site analytical testing results and productivity, and recommending improvement actions.
- Participating in site internal audits, Providing professional analytical inputs when any needs from other functions, such as supplier evaluation, validation etc.
- Managing the analytical lab to assure the EHS compliance, Maintain safe and healthy working conditions for employees under his/her supervision.
- Attend EHS training assigned and ensure that employees who report to him/her attend required training. -Ensure to submit Near Miss reports and other opportunities to improve the EHS Program. Adhere 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.
- Promote and support team development activities.
- Impart training to workmen and staff on GMP requirements and QMS requirements.

**_ Compliance_**
- 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 support the Analytical compliance of ISO 17025, ISO 9001, ISO 22000 and HACCP, BIS, FSSAI requirement

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