Job Description

THE OPPORTUNITY

Reporting into the overall Product Owner for Serialization and Digital Twin, this role is responsible for ensuring process adherence of Serialization global process in the Asia Pacific and EMEA regions. The candidate will work closely together with serialization regional leads and other business stakeholders, with market-based teams, and with other teams in Digital Manufacturing Division and the broader supply chain organization. The candidate will be responsible to meet compliance with country serialization regulations and ensure computer systems validation in accordance with business requirements. The two main serialization IT products used are SAP ATTP (Advanced Track & Trace for Pharmaceuticals) and SAP ICH (Information Collaboration Hub) which is a cloud based platform for exchanging serialization information with partners and supply chain stakeholders.

WHAT YOU WILL DO

Ensure serialization processes are efficient, stable, reliable, compliant and well supported by IT systems (primarily SAP ATTP & SAP ICH)

Process Stewardship for pharmaceutical serialization process adherence in Asia markets

Ensure optimal use of application by business and identify business process improvement opportunities

Track evolving pharmaceutical serialization compliance requirements for Asian countries and validate system solution delivery as per required regulatory requirement

Serialization Data management, data audits, monitor & review data changes

Liaise with different stakeholders like in-market business teams, packaging site leads, Logistics team and business partners like CMO, Customer and 3PL to ensure business continuity in Asia markets

Monitor system performance KPIs and ensure IT partners follow SLA to maintain business continuity

Work with IT support team to determine solutions for business requirements. Participate in bug triage and prioritization

Interface Management and issue resolutions with external business partners and SAP ICH

Perform scoping, process mapping, fit-gap workshops for projects/enhancements, solution validation and cutover data management

Manage new market onboardings, business readiness with respect to system solution, master data, interfaces, trainings

Change Management, Knowledge management, User Trainings, Access Management, User experience management

WHAT YOU MUST HAVE

5+ years of experience as a Business Analyst or IT Analyst in pharmaceutical serialization domain

3+ years\xe2\x80\x99 experience in Enterprise Serialization System SAP ATTP- Data cockpit, country regulatory reporting solution, master data setup, AIF error monitoring, Serial number management, Business Transactions etc.

Experience working in regulated, healthcare environment in pharmaceuticals

Strong knowledge of Pharmaceutical Serialization, GS1 Standards and related technologies (EPCIS)

Knowledge of Pharmaceutical Track and Trace regulatory reporting requirements

Knowledge in GS1 standards (GTIN, SGTIN, GLN, SGLN, SSCC, GCP)

Business process knowledge on pharmaceutical products packaging, aggregation, barcode printing and verification

Good experience of working with SAP ATTP integration with SAP ECC, packaging line management solution and SAP ICH

Strong verbal and written communication

Strong analytical and problem-solving skills

Flexibility in handling assignments and tasks

PREFERRED TO HAVE

Understanding of GxP environments

Knowledge of Warehouse Management Systems like SAP WM, EWM

Inbound and Outbound logistics in SAP ECC

Integration of SAP ATTP with Tracelink, SAP ICH

Experience on Tracelink, AII-OER

Knowledge of master data setups in ECC

Ability to work in a collaborative, cross functional, global team

Proficient in MS Office products word, excel, visio etc.

EDUCATION

Technical degree (engineering and/or computer science)

Bachelor\xe2\x80\x99s degree in Pharmaceutical

MBA or equivalent

Current Employees apply

Current Contingent Workers apply

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills: Data Management, Pharmaceutical Industry, Quality Management, Serialization, Supply Chain

Preferred Skills: Auditing (Inactive), Auditing (Inactive), Business, Business Management, Business Management Training, Business Process Analysis, Business Process Development, Business Process Improvements, Business Process Integration, Business Process Modeling, Business Requirements Gathering, Business Service Management, Business Support, Change Management, Client Onboarding, Communication, Compliance Reporting, Computer Engineering, Logistics Management, Logistics Operations, Master Data, Onboarding, Oracle Warehouse Management, Packaging, Pharmaceutical Sciences {+ 13 more}

Merck & Co.