Operations Specialist

MSD| Date Posted: 3-Apr-2019
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Job Nature:
Permanent
Position Level:
Entry Level
Qualification:
Diploma

Job Description

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare

 

MSD Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

 

Key Responsibilities

  • Assist the Production Supervisors in the allocation of resources to meet agreed production plan (through weekly Planning meetings) and prioritize any other shop floor ad-hoc activities.
  • Assist Production supervisor in management of compliance and technical skills training for shopfloor staff
  • Completes post manufacturing batch documentation review and leads initiatives to improve straight through documentation.
  • Acts as the IPT SAP Super-User; coordinates SAP shutdown maintenance and supports all SAP inventory updates and reversals; release PO; Good receipt DO into SAP.
  • Data collection - for APR, Profit planning and management of Tier process.
  • Prepares and issue necessary documents for production use. These documents are  the  batch records, manufacturing labels and other essential documentation related for production such as SOPs and Job Aids.
  • Leads the changes executions for manufacturing documentation in liaise with other departments in Pharm such as GTO/Process Engineering, Quality and Manufacturing. This includes emergency changes related to the batch documentation when needed.
  • Supports development of a continuous improvement framework within the overall IPT improvement program.
  • Processing of POs for non-BOM items to support IPT operations.

Manufacturing Excellence

  • Prepares and issue necessary documents on a timely manner for manufacturing use.
  • Supports document revision (SOP, Forms and etc.) when necessary to improve the system of documentation review, issuance and preparation.
  • Completes manufacturing batch record review in accordance with cGMP requirements.
  • Maintains the proper filing and safe keeping of all relevant manufacturing documents and have it available when needed including controlled copies

Batch Documentation Reviews

  • Completes post manufacturing batch documentation reviews
  • Provides straight-through document accuracy metrics and leads associated improvement initiatives
  • SAP & MES User and Inventory Updates
  • Raise WOs, update BOMs for Pharm West products
  • Test script execution for MES changes to MBR
  • Ensures SAP inventory accuracy and supports manufacturing related stock adjustments and/or reversals
  • Create, release and close PO for products

 Others

  • Data collection and metric tracking to support Tier process
  • Update APR and CPV for nominated Pharm West products

 

Continuous Improvement (Cl)

  • Utilizes Lean Six Sigma Tools (Six Sigma, Kaizen, SMED, 5S etc) to support execution of continuous improvement projects to increase agility, flow, throughput and reduce cycle time and inventory
  • Initiate Cl activities in area of responsibility - Batch document simplification, SOP & JA process review etc.

 Quality

  • Ensures that all assigned task related to manufacturing documentation support is in accordance with good manufacturing practices.
  • Prepares or update SOPs and related documents to ensure compliance with regulatory standards.
  • Actively engages in audits and supports implementation of agreed follow-up actions.
  • Safety, Health & Environment
  • Ensures that all assigned daily manufacturing activities are planned  and carried out in accordance  with SHE requirements
  • Participates in (as required) and supports the implementation of actions for all incidents Investigations and Audits
  • Ensures all permitting requirements are met for all lPT maintenance activities on the day shift
  • Promotes SHE leadership behaviours and engages employees at all levels on SHE issues
  • Ensure Incident Investigations and Audits are fully supported with improvement actions implemented

 

 

 

Qualifications

  • Diploma qualification with 3 - 4 years (preferred) in an operations environment with experience in documentation preparation and control preferred
  • Good knowledge in applicable regulations and divisional policies/guidelines (especially Cleaning/Housekeeping/Maintenance, Environmental Control,Process/Cleaning/ Equipment Validation, Change Control and Manufacturing Practices)
  • Good stewardship awareness (including cGMP, regulatory inspection preparation, SHE)

 

How to Apply?

 

Interested candidates can submit their application online through MSD Career site. If you need further information, you can email Isabel Petallar [Click Here to Email Your Resume].

 

What we offer at MSD?

 

Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.

 

Search Firm Representatives, Please Read Carefully: 

 

MSD is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.  No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means. 

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