Site Name: India - Maharashtra - Nashik Site
Posted Date: May 27 2024

Job Purpose

To meet the safety and quality requirements for Eltroxin Tablet Department.
To develop, coach and lead the production and Packing FLLs team while ensuring the team is scheduling and managing the resources required to support current and future business needs.

Key Responsibilities

Co-ordinating with other department

To liaise with Project Team for New product launch & other projects of Eltroxin Facility.
To coordinate with EHS and Quality dept. for continuous improvements in the facility.
Meeting with OEMs of the new machines.
Validations of Eltroxin product and machines with PR&D, QA and Engineering.
To ensure QMS compliance in the department.

Audits

To ensure that facility is maintained for Inspection Readiness.
Conformation of department IBM audits and MM audit review

Reviews

To carry out review of MFRs and BMRs with version controls.
To ensure EHS risk assessment review and compliance for dept.
To ensure that SOPs are reviewed in the department and arrange for training.

General

Round in manufacturing area and ensuring morning department performance review meeting and area readiness.
Review CCs/PDRs, CAPA for dept.
Conduct one to one meeting with department M.S.
To ensure that proper discipline is maintained in department.
Ensure CAPA compliance.
Ensure ZAP/ZIP/ZWP implementation in department.
Control department financial budget within limit.
Plan for mitigation the identified and escalated risk in the department.
Business planning to achieve departmental targets.

Knowledge/ Education / Experience Required

Educational Background : B. Pharm/M. Pharm, with ≈10 years experience in Tablet Manufacturing

Area of Specialization :

OHC 5 compound handling experience.
Sound management knowledge / technical knowledge / project knowledge.
Managerial skill & Leadership skills.
EHS & Quality area exposure

Other Job-Related Skills/Background

Excellent communication skills and the ability to build relationships at all levels and across functions.
Sound knowledge of ‘audit’ requirements from quality and safety perspective within the pharmaceutical business.
Ability to build relationships (Team building ) at all levels and across functions.
Work with theFLL team and CFT to finalize line / area daily targets w.r.t. to safety, quality & service which are aligned to site goals.
To ensure the proactive planning of required resources, Raw material / Packing Material and non-coded item required to perform the day to day activity and coordination with line support function.

Weekly performance review of the department to identify top issues and proactively work on improvement projects.
To ensure that manufacturing/packaging is carried out according to SOP, BMR , BPR.
To ensure cGMP practices are followed for all time inspection readiness (Area & facility up keep & cleanliness, status labelling, good documentation practices etc).
To carry out Production documentation output by using d-MERP (SAP System).
To review and approve documents (BMR/BPR) in SAP system.
To ensure production staff is following instructions of SAP system to check the WM Staging material, Assign RF device to PO, Assign HU to process order, Create HU, Issue material to PO, Goods Receipt, Move GR material to Return to Warehouse.
To review and approve the Universe of management monitoring for smooth monthly self inspectoins w.r.t. EHS/Quality as per schedule to identify gaps & timely closure of actions.
To identify risk proactively in area which could have impact on safety, quality & service.
To handle deviation related to the respective area. Effective use of RCA & CAPA tools. Close deviation within 22 days from date of initiation.
Tracking of staff leave and promote for plan absenteeism. Unplanned absenteeism cases to be handle as per standard procedures.
Encourage staff for proactively identification of unsafe condition & unsafe behavior. Report it through ZAP process.
Build an culture of reporting safety incidents and its closure with in 10 days with appropriate CAPA.
Drive line level improvement with an approach of Kaizen & CIF.
Timely preparation / approval in system of area documents like SOP/BMR/BPR/Logbook etc.
One on one discussion with staff to maintain discipline and building their capabilities.
Coaching/counseling of staff for adherence to standards related to safety, quality & delivery.
Quarterly Performance discussion with staff and recording the same in PDP cards.
Coordination & monitoring of dept consumables & inventory.
Tracking of pkg line or machine OEE and output
Embed GPS ways of working by effective utilization of GPS stds/ tools like
Ensire Tier 1 Performance management meetings are in place in use.
Understanding & Problem solving of Top 3 issues of area.
Actively engage team for continuous improvement.
Appropriate standardization for completed improvements/change for better sustainance
Process confirmations against the 4M’s Man, Machine, Method & Material.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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Operations Manager - Eltroxin