Associate Manager - Source Q&C Job (Jakarta Raya, ID)

Description

Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products. We've been privileged to play a role in helping millions of people all over the world be well and stay well for more than a century of change through our various products of consumer, medical devices & diagnostics and pharmaceuticals.

We have more than 275 companies located in 60 countries, selling more than 175 products worldwide and employ 128,000 qualified employees around the world. With our strong Credo based values and culture, people are our greatest assets. We believe that attracting, developing and retaining our employees are essential to our success.

Position Description

Execute overall Q&C mission, vision and OGSM for the EMs, Raw and Packaging Material Suppliers, and support to Local

Operating Company (LOC), through:

? Credible representation of and active involvement in the highly effective and respected Q&C organization.

? Interdependent partnership with Regional Q&C and other affiliate

? Close collaboration with R&D, SMP, TT, Global Engineering, Regulatory, Supply Chain, CLS, Operations, EM, SQM,

Marketing, and Customer Development teams.

Scope of the Role and Basic Purpose

? Support compliance to Regulatory authority, Enterprise and Sector Quality & Compliance requirements for EMs,

Suppliers, and LOC.

? Establish, implement and maintain robust Quality System of EMs and Suppliers, particularly on Internal Audits, Audit-

Readiness, INV/CAPA and Change Control effectiveness.

? Support achievement of goals in GOC metrics.

? Support supplier quality management in the site.

? Ensure robust micro risk prevention activities in EMs.

? Support Zero Defect initiatives for EMs and suppliers.

? Ensure timely and comprehensive investigations of quality issues, including complaints, at EMs and Suppliers.

? Support new product launches related to EMs and Suppliers.

? Effective administration of enablers to strengthen quality systems, e.g., EtQ, GSS, SAP, Master Data

Qualifications

Qualification, Competencies & Skill Required

? Education min S1 Degree from Pharmacy/Chemistry/Biology or related subjects

? Min. 5 years’ experience in quality management role in a Pharma/OTC/Cosmetic FMCG

? Preferred for having the Lead Auditor Certificate.

? Ability to identify requirements for a high level of GMP compliance in Quality systems, and implement the necessary programs

? Sufficient knowledge of local regulations, cGMPs, Policies, Enterprise Standards, WWSP’s, QSP’s and other Quality Systems and Guidelines.

? Ability to interpret and apply local regulations, cGMPs, Policies, Enterprise Standards, WWSP’s, QSP’s and other Quality Systems and Guidelines.

? Use of good judgment regarding acceptability of product, and making decisions even though the issues may be complex

? Results oriented and able to independently create and deliver

Strategic thinking

? Analytical and process-oriented

? Sufficient knowledge on manufacturing processes

? Good communication and presentation skills

? Decision making and problem solving

Primary Location:Asia Pacific-Indonesia-Jawa-Jakarta Raya
Organization: P.T. Johnson & Johnson Indonesia (8150)
Job Function: Quality (Generalist)
Job Segment: Assistant Manager, Medical, CAPA, Law, Engineer, Management, Healthcare, Legal, Engineering

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