[Innovative Medicine] MSAT (Manufacturing Science & Technology) Senior Manager (Small Molecule Drug

職務 概要 Position Summary :

1.

The launch of new technology, products and technical transfers.

2.

The validation process and execution (Process and Cleaning Validation).

This includes lifecycle

management of products (including continuous improvement).

3.

Packaging engineering - including the management of packaging specification for new and

current packaging material (primary, secondary and tertiary).

Also includes artwork

management.

法規制の順守に関する責任 Regulatory Compliance Responsibilities:

1.

Good Manufacturing Practices (GxP)

l Adhere to applicable cGxP's and procedures & local Japanese regulatory requirements.

l Report incidents and deviations

l Propose solution to improve compliance with cGMP's

2.

Safety, Health and Environment Performance

l Adhere to applicable EH&S and procedures (role model).

l Correct use of the available personal and protective equipment.

l Reporting of good saves, accidents, incidents, deviations.

l Cooperate on and suggest solutions to improve EH&S.

l Actively promote EH&S, support campaigns/programs such as "Safe behavior".

主な職務及び主な責任 Major Job Duties and Responsibilities:

Manage Product Transfer /Product Introduction for the Site

l Manage the NPI Manager to ensure:

Ø Products are launched on time and in full.

Ø NPI projects followed the necessary standards.

Ø NPI projects are achieving plans on target.

Where gaps/challenges exist provide the necessary support to the team to overcome these challenges.

Ø Manage NPI stakeholders together with NPI manager to ensure issues are escalated

appropriately and that the team is well supported.

l Work with Regional, Global and Local leadership teams to set the vision for the site's and

region's technology roadmap.

l Develop the NPI team through regular performance and career conversations.

Validation Processes and lifecycle management

l Manage the Validation (group) Manager to ensure:

Ø Validation processes are followed in alignment with global Janssen procedures as well as

local regulatory requirements.

Ø Validation processes are followed as per standards, including the maintenance of the

Validation Master Plan.

l Lead or support complex failure investigations (escalation of quality or compliance events).

Packaging Engineering

l Manage the packaging engineers/packaging SMEs to ensure:

Ø Evaluate and implement packaging solutions to meet local market requirements.

Ø Correct management of materials against the standard.

Ø Packaging Innovation and new technology introduction.

Inspection Readiness and Execution

l Technical support in partnership with Quality on any regulatory audits and inspections

l Support through the TO team organization audits including preparing and delivering

presentations, explanations, etc.

Organizational Leadership

l Accountable for managing team in accordance to Site and Technical Operations priorities

following the JSC Business Cascade (Budgeting, Reso...