Job Description

Title: Senior Manager - Corporate Quality Policies and Standard

Date: Sep 8, 2022

Location: Tandalja - R&D

Company: Sun Pharmaceutical Industries Ltd


Overview:
The Senior Executive / Manager-II Corporate Quality Training Programs reports to the General Manager Corporate Quality Training. The Senior Executive / Manager-II Corporate Quality Training will lead the design and development of Certification programs focused on improving cGMP compliance and is expected to partner with key stakeholders to ensure Certification programs are properly maintained, implemented and communicated across sites.
Responsibilities include:

• Responsible for the development, implementation and management of Corporate Quality Training Programs that support compliance objectives, applicable to regulatory requirements, local and global processes.

• Manage the in-house or outsourced, global certification programs based on the company demand.

• Accountable for creation and management of course curricula and evaluation tools with the objective of maintaining a state of audit readiness and aligning training requirements with business and employee needs.

• In partnership with relevant parties, establish role competencies, expectations towards certification and customization of the training material if needed. Ensure that course materials are customized and continually revised to accurately reflect organization, regulatory or business processes changes.

• Work in partnership with team of trainers and Subject Matter Experts (SMEs) and ensure that training and certification programs are developed utilizing the most effective methodologies (e.g. Classroom, e-Learning, pre-assessments, and assignments).

• Ensure that all certification training documentation is consistently and systematically maintained in a timely and effective manner, in compliance with relevant regulations. This includes course materials, and training records.

• In partnership with site training personnel ensure traceability of training completion and develop and maintain training metrics towards measurement of success and effectiveness.

• Assess training program and qualification strategy effectiveness at the site level and provide local support as necessary.

• Ensure timely relevant solutions and training programs are in place to address strategic learning requirements, customer needs and compliance commitments.

• Support internal, external, regulatory and customer audits when required

• Interact with other Corporate Quality individuals to assure quality systems and procedures for use in reporting monthly metrics (KPIs).

• Maintain systems to track and trend key quality system indicators and ensure monthly KPIs are issued on time and any deficiencies noted are promptly addressed.

• Ensure consistent and flexible approach towards global regions time zones and travel if required to deliver training.

• Works as a member of a team to achieve all outcomes.

• When necessary, maintains short-term performance goals, training plans, and monitors results to reflect a changing environment

• Maintain a working knowledge of eDMS, LMS and other software’s relevant to the training program to allow proper communications with stakeholders

• Develop and maintain curriculum for the training programs in LMS

• Identify global learning tools and solutions that enable access to critical learning content “on demand” to support real time training (websites, shared drives, video tools, etc.)

• Participate and/or conduct regular Corporate Training update meetings with site training coordinators (forum) as required

• All other duties as assigned

• Bachelor's or Post Graduate Degree Life Sciences, Pharmacy, or equivalent required Experience Requirement.

• 8-12 years working in a pharmaceutical environment
• At least 5 years program management within a Pharmaceutical Quality Environment, preferred.
• Strong understanding of GMP requirements and their application in a manufacturing environment, knowledge of international GMP requirements

• Working experience in design and implementation of training programs, LMS, TrackWise, LIMS is preferred

• Ability to function as a project manager with a multi-cultural team in a global environment
• Excellent communication, presentation, technical writing and inter-personal skills
• Ability to work independently, take initiative and lead, inspire and motivate a team
• Ability to remain focused and effective in high stress situations
• Computer literate (MS Office, MS Project or equivalent)
• Must have English language fluency, both written and verbal, with the ability to communicate at all levels within the organization.