Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
You will be a member of Pfizer’s dedicated and highly effective Technical Services team. Your methodological approach will help us ensure compliance of our quality systems with company standards and government regulatory requirements. Your problem-solving ability will help us troubleshoot validation and packaging development problems. Your documentation skills will guide the writing and review for packaging development and validation process documents.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.
It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Contribute to the completion of packaging development projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
On time submission for packaging/artwork development based on BPOM grace period.
Determine improvement opportunities for packaging/artwork development process (including legacy process).
Coordination with supply chain, procurement, regulatory, production and quality to ensure on time implementation of new artwork/packaging.
Assists with development of validation protocols and manage Regulatory queries and responses.
Participate in deviation investigations to identify root causes and define corrective and/or preventative actions.
Adhere to all company and Good Manufacturing Practices {also cGMP} procedures, along with safety regulations within the plant and participates in developments of validation programs as needed to remain current with cGMPs and industry.
Report to the Validation Supervisor, to assure that equipment, facilities, and utilities are validated in accordance with {Current} Good Manufacturing Practices {part of GxP} principles, regulatory requirements, and company policies and standards.
Define problems, collect data, establish facts, and draw valid conclusion for validation activities.
Qualifications
Must-Have
Bachelor's Degree in Pharmacy
Excellent attention to detail and working knowledge of Good Manufacturing Practices
Excellent organizational skills, and ability to handle changing deadlines
Strong communication with written and verbal skills (English is preferable)
Working knowledge of Microsoft Office (e.g. Word, Excel)
Nice-to-Have
One year experience in packaging/artwork development/validation in pharmaceutical industry
Pharmaceutical Industry with validation experience (such as packaging, process, equipment and or cleaning validation)
Basic knowledge or familiar with Adobe Illustrator
Have passion in packaging/artwork development
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control
#LI-PFE
Addressing any issues in a timely fashion.
Cooperating with the general manager, and assisting with anything from project planning to staff management.
Maintain accurate electronic spreadsheets for financial and accounting data.
Check figures, postings, and documents for correct entry, mathematical accuracy,â¦
Maintain site level Master Data to analyze and resolve capacity constraints in order to support manufacturing Statement of Supply commits in the tacticalâ¦
Memiliki pengalaman yang sama di bidang yang sama min. 2 tahun (lebih diutamakan).
Memahami MS Office / SAP.
Bertanggung jawab atas akurasi data serah terima.