Career Opportunities: SENIOR EXECUTIVE (21005)

Requisition ID 21005 - Posted  - BIOCON LIMITED - API MAINTENANCE - India

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Department Details

Role Summary

Adherence to standard operating procedures, Safety, cGMP and EHS requirements.
Ensuring adherence to the established HR policies, Standing Orders & other established procedures of the Company.
To ensure safe working environment for the employees.
Establishing and Propagating EHS Management System awareness.
To attend the Safety Committee meetings.
Implementation of cGMP.
Implementation of energy conservation measures.
Imparting training to the below hierarchy level on SOP's, IOP's and Process related aspects to maintain quality and consistency.
Preparation of documents & records related to Quality (Deviation reports, change controls, CAPA, etc...) and EHS management systems.
Planning and procurement of spares and consumables.
Planning and execution of different types of maintenance of equipment and its accessories in co-ordination with users.
To ensure smooth running of audits (internal and external) related to Quality and EHS management systems.
To ensure all the audit findings are closed within the stipulated time.
Reporting of non-conformities, adherence, initiation, and implementation of the corrective/preventive actions as suggested by Quality Assurance.
Issue of documents for data entry and recoding related to Calibration and PM.
Verification of calibration/PM as described in the SOP's.
Preparation of equipment/instrument qualification documents and SOPs.
Documentation and data control.
Maintenance of records.
To coordinate with QA for all the validation, qualification, and Audit preparedness.
Data entry in log sheets and checklist as described in the SOP's.
Issue of work permits.
Planning of different types of maintenance of equipment and its accessories in co-ordination with users.
Execution of different types of maintenance of equipment and its accessories in co-ordination with users.
To ensure all equipment's and instruments are operated and maintained as per manufacturer's recommendation.
Co-ordination of contract services for the equipment's and instruments.
Co-ordination for HAZOP study.
Issue of gate pass.
Inventory management.
Creation of purchase request.
To acknowledge the receipt of material, service, invoice, etc....
To delegate the roles and responsibilities for the reporting personnel.
To set objectives and targets for the reporting personnel.
To lead & motivate team members to achieve the set targets.
Responsible for CAPEX requirements (Plant and Machinery modifications) with reference to cGMP, safety and productivity improvement needs.
Execution of Plant and Machinery modifications.
Ensuring all the new Projects and Processes are executed as per agreed upon timelines and Quality.
To have Knowledge in creation of roles /trainings & self-leaning in digital platform like (SAP Success factor, learning suite etc..).
Creation of standard operating procedures in Procedure module (FileNet software, DMS etc..).
Knowledge in handling, trouble shooting of PLC / DCS / MES related hardware & software.
Knowledge in handling of clean room applications (EMS, BMS etc..), equipment's & concepts.
Planning, Coordination & Execution of HVAC Validation activities and equipment Qualification / Requalification

Key Responsibilities

Adhere the established procedures and policies of the company.
Ensuring adherence to the established HR policies, Standing Orders & other established procedures of the Company.
Implementation of CGMP in workplace.
Ensure all the audit findings are closed within the stipulated time
Identification of training needs in the department
Ensure safe working environment for the employees.
Planning and procurement of spares and consumables
Costing and Budgeting for the department.
Planning and execution of different types of maintenance of equipment and its accessories in coordination with users
To delegate the roles and responsibilities in the department
Minor Decision making on priorities.
Delegate the roles and responsibilities to the downline persons in the department
Implementation of energy conservation measures.
Review of documents for data entry and recoding related to Quality (Deviation reports, change controls, risk assessment etc.) and EHS management systems (work permits).
Review of QMS (change management, related activities in digital platform like (track wise, DMS etc....)
To ensure smooth running of audits (internal and external) related to Quality and EHS management systems.
Reporting of non-conformities, adherence, initiation, and implementation of the corrective/preventive actions as suggested by Quality Assurance.
Review of documents for data entry and recoding related to PM.
Carryout/review of Preventive maintenance / predictive maintenance activities as per schedule and guidance of superiors &procedures.
Preparation/execution/review of equipment/instrument qualification documents as per procedures & guidelines. Handling of online qualification software (Val Genesis etc.)
Maintenance of Documentation and data control.
Initiation of work permits in coordination with EHS & CFTs.
Execution /review of different types of maintenance of equipment and its accessories in co-ordination with users.
To ensure all equipment's and instruments are operated and maintained as per manufacturer's recommendation.
Co-ordination with contract services providers for the equipment's and instruments AMC / Break down service.
Co-ordination for HAZOP study.
Preparation/ review, tracking, handling & closure of gate pass in digital platform like (ERP, SAP etc...)
creation of roles /trainings & self-leaning in digital platform like (SAP Success factor, learning suite etc..).
Creation of standard operating procedures in Procedure module (FileNet software, DMS etc..).

Educational Qualifications

Required Education Qualification: B.Tech
Required Experience: 6 - 8 years

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