Job Description

Responsibilities

1. Contribute to the maintenance of training programs for the COMET system.

2. Provide COMET training to site personnel.

3. Management of SAP site material master:

Create, update and maintain PCR traces to link change controls with SAP.

Create and update Quality info record to allow Supply Chain to order components from the approved suppliers.

Update and maintain RCT changes to support finished good sales.

Maintain inspection plans to support lab results recording in SAP.

Create and maintain certificate profiles for finished goods CoA printing.

Maintain material shelf-life changes in SAP for finished goods and components.

4. Site Topic Lead and QA support for Computerized Systems

5. Providing the independent quality review of computerized systems documentation to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle.

6. Support development and implementation of DI Global Procedures (workshops, document reviews, pilots, deployment and implementation)

7. Responsible for collection and presentation of DI compliance (metrics), obstacles and challenges to site management, including a review of the DI topic at the Site Quality Council Meeting per the QC standard

8. Site Topic Lead for Data Integrity (DI) including:

Development and oversight of the annual DI work plan / coordinates between site/functional management, site/functional SMEs and DI COE

Implementation of a DI GEMBA program within site / functional area

Supports site for DI Inspection Readiness / Inspection Responses for DI

Active participant in DI Knowledge Management Forum / Community of Practice

Distribution of DI information within the site / functional area, and from the site / functional area to the DI COE

9. Perform periodic audit trails / Orphan data

10. Create, revise or review Empower methods in working projects.

11. Participation in Health Authority, global quality, internal, & external audits. 12. Participation in deviation initiation and investigations, Quality Risk Management and Change Control Systems.

13. Act as risk lead or quality representative in product quality risk assessments

14. Initiate and complete change controls

Behavioral Attributes

Able to make unbiased and honest judgements.

Able to deal with situations requiring interpretative and evaluative thinking.

Limited supervision required in day-to-day activities. Listening, integrating diverse perspectives, adds value to the achievement of team goals.

Timely decision making.

Must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.

General

Responsible for reporting adverse experiences or events (AEs), adverse device events (ADEs), product quality complaints (PQCs) and other reportable information, customer feedback (CF), alleged counterfeiting, diversion and tampering (CDT) that they become aware of to the Designated Point of Contact (DPOC).

Qualifications and Education Requirements

Bachelor's degree or National Diploma. Preferably Information Technology, Engineering, Commerce or equivalent.

Experience:

Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing and/or laboratory operations.

At least two to five years of experience in delivering Computerized Systems such as SAP solutions or an application support role.

Good understanding of the current pharmaceutical industry and applicable regulations, with emphasis in regulatory expectations (SAHPRA).

Must demonstrate working knowledge of the principles, theories and concepts of computerized system compliance.

Familiarity or practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.

Experience in supporting regulatory inspections.

Skills

Business engagement skills, with ability to collaborate with both technical and non-technical roles.

Excellent oral and written communication skills including persuading others and developing cross functional relationships.

Analytical problem-solving skills applied to issue identification and resolution

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):

Merck & Co.