Senior QA Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

PRINCIPAL RESPONSIBILITIES:

Shopfloor management: Daily supervision and inspection of GMP implementation, timely fill in inspection records, timely proposed corrective and preventive measures for findings, and supervision of the results of inspection and implementation.

File Review:

 Review manufacturing batch records and packaging batch records, SAP system maintainance and delivery in a timely manner;

 Review new product trial batch records, reprocess batch records, reprocess orders, engineering lot and validation lot batch records;

 Review and approve blank batch records within the specified time frame

 Review approval master data

System management: shopfloor management and investigation of noncompliance incidents, ensure root cause identification and corrective preventive action. Track implementation results; perform production impact assessments of changes and track implementation activities; manage, monitor rejection and return products in accordance with GMP requirements; track closure of CAPA; handle customer complaints; train personnel and certify IPC.

Document drafting: Periodic review of assigned product annual review reports, PPQS and documents completed on time.

Communication and collaboration: Timely communication with supervisors and colleagues, good communication and feedback with work-related departments; teamwork and cross-departmental collaboration.

Be aware of all job-related safety, environmental and industrial hygiene regulations and follow them in production.

Ensure that daily operations comply with control substance safety management system and related document requirements.

Organize the formulation of safety management documents, and guide and supervise the implementation of documents.

Responsible for guiding and supervising the safety management of the whole process of production of control substance.

Organize safety management education and training.

Responsible for the management of monitoring system and alarm device, organize regular inspection to ensure normal operation.

Responsible for the investigation, handling and reporting of anomalies and security incidents.

Organize the implementation of safety management system self-inspection and evaluate the effectiveness of safety risk management measures.

ORGANIZATIONAL LEADERSHIP

 Training: Conduct on site Gemba Walk, file review, and document drafting training for new site QA personnel

 Engage in the Global meeting to oversight cross contamination program and update the correspondence document.

Join in other project if needed.

KNOWLEDGE SKILL AND ABILITY REQUIREMENTS:

 Personal attitude and mindset

Drives for innovation and change to ensure competitiveness

Can-do mentality, agility & flexibility able to work with stretched goals and deadlines

Willing to place the goals of the team first and work with others towards these goals

Communicative/Motivator/Negotiator/assertive person having impact

Showing a high sense of responsibility regarding professional activities

Ability to deal with changes from market,compliancesuppliers and others.

 Good Manufacturing Practices(GMP)

Adhere to applicable cGMPs and procedures (role model)

Report issues and deviations

Propose solution to improve compliance with cGMPs

RELATED EXPERIENCE:

5 years working experiences in pharmaceutical industry, 3 years working experiences in MNC

DEGREE:

Bachelor degree or above in pharmaceutical, chemical, biochemical, pharmaceutical etc.

LANGUAGES:

Fluent in written and spoken Local Language (ideal not a must)

Must = Fluent in written and spoken English