Lab Analyst and Training Coordinator

To ensure compliance of the Training Management system at Site by liaising with the departments, ensuring all the employees are trained, competent and the compliance needs are met. 

Release of good quality packaging material in line with approved standards and specification to support business and ensure smooth production operations by timely release of packaging components.

Education, Skills & Experience

• Bachelor’s degree in sciences, Engineering, Business or Pharm‑D is required for this role.
• 1- 3 years of experience in a preferred role.
•  Understanding of regulatory requirements including GMP and compliance training where required. Train the trainer certification would be beneficial.
• Good communication and presentation skills.
• Stakeholder and conflict management.
• Strong public speaking ability and conducting ILT session (small and large scale).
• Experience of handling groups of people including non- management.
• Proficient in MS Office (Word, PowerPoint and Excel).

Responsibilities

Training Coordinator:

• Implementation of the organization, personnel and training management system at the Site in- line with the global/ QMS training standards and policies, ensuring the in- place and in- use of the local procedure, policies and QMS requirements, obtaining TC 02 access in myLearning, smooth handling of the system and execution of the projects
• Ensure timely completion of trainings on monthly basis through periodic follow ups with the individuals, dept managers and learning reps across the Site, assessing the impact in case of any overdue, escalating to the relevant stakeholders and reporting to the SQC including mandatory and annual GMP refreshers
• Ensure monthly KPIs are monitored, managed and reported throughout the month, to the SQC and regional governance forums along with attending all the site- based or regional forums with timely provision of the data and completion of the actions as per the timelines, share knowledge of the forums and implement actions at the site level.
• Perform the management monitoring and participation in the independent business monitoring of the training system at site to ensure effectiveness.
• Analysis of the training needs in collaboration with the departments based on criteria defined in the TNA, updating the TNA on monthly basis with the SOPs included or deleted, change in the roles & responsibilities and training delivery method.
• Ensure all the SOPs and OJTs are existing in myLearning as learning items with timely assignment of the questionnaires, curricula are updated electronically in-line with the TNA in VQD as well as in myLearning.
• Support the delivery/ facilitation of learning & development interventions such as deviation investigation and root cause, customer complaints, recalls, out of specs or where appropriate.
• Conduction of the new employee’s induction on timely basis, review of job descriptions and their assignment, job codes in myLearning and organograms are updated.
• Timely closure of all the CAPAs/ actions for risks, deviations, management monitoring, independent business management, change controls, annual reviews etc
• Development, adherence and approval of the learning calendar based on different systemic reviews and outcomes of the previous year, assigning, scheduling ILTs, marking in myLearning and reporting in the SQC 
• Facilitate and ensure TtT of all trainers at the Site.
• Perform periodic review of all training related material such as packages, job descriptions, TNA, curricula, organograms and others to ensure they meet the minimum GMP requirements.
• Develop capability frameworks to ensure the right capability is embedded across the organization and to support the site in the 70/20/10 development of the employees based on the capability models and their outcomes.
• Perform annual review of the compliance training system and drive continuous improvement through employee’s performance reviews and projects to simplify and modernize the training methodology.

Pack Lab Analyst:

• Checking of artworks, bromides, machine proof, & buying samples as per standards and regulatory requirements with respect to formulation RN & ML Nos., Storage conditions& Address to ensure GSK requirements are met and to avoid any Regulatory sanctions. To check the total artwork after the input of concerned Departments so that all the requirements are fulfilled in the Artworks
• Conduct Management monitoring audits to ensure compliance. Meeting with Supplier’s for on-line complaint and rejections in order to facilitate the supplier in CAPA so to avoid recurrence in future supplies
• Preparation of monthly report of the section, Vendor complaints & rejection data for supply review meetings and site quality council
• Preparation /Review of specifications /test methods, SOP’s of packaging material to ensure compliance and ensure in-use of SOPs
• To manage calibrations and proper use of all equipment to ensure compliance.
• Updating of specification of new & revised Packaging material in LIMS
• Update specifications and requirements of Packaging Materials in SAP (d-MERP)
• Look after the Pack Management Lab as designate in absence of Pack Management Manager
• To ensure that the all the SOPs related to training, QMS, change control, risk management Record Retention activities are in place and in use
• Maintains a safe and healthy work environment
• Ensure implementation of EHS standards and guidelines in the area of responsibility.
• Reporting EHS adverse events (Near misses, Incidents and Accidents) timely.

To ensure compliance of the Training Management system at Site by liaising with the departments, ensuring all the employees are trained, competent and the compliance needs are met. 

Release of good quality packaging material in line with approved standards and specification to support business and ensure smooth production operations by timely release of packaging components.

Education, Skills & Experience

• Bachelor’s degree in sciences, Engineering, Business or Pharm‑D is required for this role.
• 1- 3 years of experience in a preferred role.
•  Understanding of regulatory requirements including GMP and compliance training where required. Train the trainer certification would be beneficial.
• Good communication and presentation skills.
• Stakeholder and conflict management.
• Strong public speaking ability and conducting ILT session (small and large scale).
• Experience of handling groups of people including non- management.
• Proficient in MS Office (Word, PowerPoint and Excel).

Responsibilities

Training Coordinator:

• Implementation of the organization, personnel and training management system at the Site in- line with the global/ QMS training standards and policies, ensuring the in- place and in- use of the local procedure, policies and QMS requirements, obtaining TC 02 access in myLearning, smooth handling of the system and execution of the projects
• Ensure timely completion of trainings on monthly basis through periodic follow ups with the individuals, dept managers and learning reps across the Site, assessing the impact in case of any overdue, escalating to the relevant stakeholders and reporting to the SQC including mandatory and annual GMP refreshers
• Ensure monthly KPIs are monitored, managed and reported throughout the month, to the SQC and regional governance forums along with attending all the site- based or regional forums with timely provision of the data and completion of the actions as per the timelines, share knowledge of the forums and implement actions at the site level.
• Perform the management monitoring and participation in the independent business monitoring of the training system at site to ensure effectiveness.
• Analysis of the training needs in collaboration with the departments based on criteria defined in the TNA, updating the TNA on monthly basis with the SOPs included or deleted, change in the roles & responsibilities and training delivery method.
• Ensure all the SOPs and OJTs are existing in myLearning as learning items with timely assignment of the questionnaires, curricula are updated electronically in-line with the TNA in VQD as well as in myLearning.
• Support the delivery/ facilitation of learning & development interventions such as deviation investigation and root cause, customer complaints, recalls, out of specs or where appropriate.
• Conduction of the new employee’s induction on timely basis, review of job descriptions and their assignment, job codes in myLearning and organograms are updated.
• Timely closure of all the CAPAs/ actions for risks, deviations, management monitoring, independent business management, change controls, annual reviews etc
• Development, adherence and approval of the learning calendar based on different systemic reviews and outcomes of the previous year, assigning, scheduling ILTs, marking in myLearning and reporting in the SQC 
• Facilitate and ensure TtT of all trainers at the Site.
• Perform periodic review of all training related material such as packages, job descriptions, TNA, curricula, organograms and others to ensure they meet the minimum GMP requirements.
• Develop capability frameworks to ensure the right capability is embedded across the organization and to support the site in the 70/20/10 development of the employees based on the capability models and their outcomes.
• Perform annual review of the compliance training system and drive continuous improvement through employee’s performance reviews and projects to simplify and modernize the training methodology.

Pack Lab Analyst:

• Checking of artworks, bromides, machine proof, & buying samples as per standards and regulatory requirements with respect to formulation RN & ML Nos., Storage conditions& Address to ensure GSK requirements are met and to avoid any Regulatory sanctions. To check the total artwork after the input of concerned Departments so that all the requirements are fulfilled in the Artworks
• Conduct Management monitoring audits to ensure compliance. Meeting with Supplier’s for on-line complaint and rejections in order to facilitate the supplier in CAPA so to avoid recurrence in future supplies
• Preparation of monthly report of the section, Vendor complaints & rejection data for supply review meetings and site quality council
• Preparation /Review of specifications /test methods, SOP’s of packaging material to ensure compliance and ensure in-use of SOPs
• To manage calibrations and proper use of all equipment to ensure compliance.
• Updating of specification of new & revised Packaging material in LIMS
• Update specifications and requirements of Packaging Materials in SAP (d-MERP)
• Look after the Pack Management Lab as designate in absence of Pack Management Manager
• To ensure that the all the SOPs related to training, QMS, change control, risk management Record Retention activities are in place and in use
• Maintains a safe and healthy work environment
• Ensure implementation of EHS standards and guidelines in the area of responsibility.
• Reporting EHS adverse events (Near misses, Incidents and Accidents) timely.

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Contact information:
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