Job Description

Location Singapore, West

Planning Area
TUAS

Job Type
Permanent

Salary
$6,200 - $8,500 Per Month

Date Posted
2 hours ago

Expiry Date
28-Jun-2022
Additional Details


Job ID
218947

Job Views
1

Roles & Responsibilities Entrusted by Pfizer Singapore, Cielo Talent supports Pfizer to recruit permanent employees for the expansion of Pfizer Tuas manufacturing site in Singapore.
Why Pfizer
Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
To learn more, visit https://www.pfizer.com.sg/working-here
For additional information on our guidelines, please visit http://www.pfizer.com/community-guidelines
Why Patients Need You
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.
What You Will Achieve
Working with a dynamic engineering team, you will play a critical part in managing the maintenance and reliability engineering activities involving the redesign, maintenance, and repair of utilities systems, buildings, and production/non-production equipment.
Your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations.
It is your hard work and dedication that will enable the organization to be ready to achieve new milestones and help patients across the globe.
Position Summary
The incumbent is a member of the Quality Assurance team. Reporting to the Senior QA Manager, the incumbent will be responsible for the following:

• Provide Quality Assurance oversight to site operations (primarily Production, Quality Control, Warehouse, Engineering) to ensure products produced are in compliance with Pfizer Quality Standards (PQS) and ICH guidelines.
• Work with supply chain and downstream / drug product sites to ensure timely delivery of quality products.
• Support regulatory team to file products and address regulatory queries in an accurate and timely manner.
• Understand regulatory expectations and support site inspection readiness.
• Drive quality culture and promote GMP compliant behaviours at the site.
• Drive improvement of quality systems in collaboration with cross functional teams.
• Contribute to achieve our vision of being best in class manufacturing site, producing highest quality products in the safest way.
• Deploy and use Imex "way of working" for day to day operations, problem solving, escalation and continuous improvements.
• Lead specific areas of QA oversight as assigned and delegate for Senior QA Manager as required.
• Mentor members within the Quality Assurance team.

Responsibilities:

• Lead specific areas of QA oversight (e.g. Production, Investigations) to support routine production.
• Review and/or approve site procedures related to Quality Assurance systems.
• Lead improvement of quality assurance systems, as necessary.
• Responsible to review and approve recipes and GMP documentation (e.g. SOPs, batch records, protocols and reports, change controls, risk assessments) associated with Facilities and Equipment, Materials, Production, Laboratories, Packaging and Labelling to ensure batches are produced and tested in compliance with site procedures and regulatory registered specifications.
• Collaborate in cross function teams (e.g. Production, Quality Control, Warehouse, Supply chain personnel) to provide QA support for end-to-end adherence to production schedule.
• Review and approve deviations and laboratory investigations according to site procedures. This includes reviewing and approving the investigation reports, ensuring the adequacy of the root cause analysis and associated corrective actions and/or preventive actions, performing the impact assessment with the subject matter experts for quality/validation/stability/regulatory impact. Ensure issues are escalated according to site procedures.
• Handle product complaints. Ensure complaints are investigated thoroughly with effective CAPAs to prevent recurrence.
• Participate in process risk assessments (e.g. FMEA) as part of new product introductions and/or process changes.
• Participate in gap analysis of site procedures against PQS and propose required actions to address identified gaps and mitigate risks. Conduct internal audits to ensure the internal controls are effective.
• Disposition intermediates and active pharmaceutical ingredients (API).
• Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state and adhere to site procedures and PQS.
• Support the maintenance of validated state of GMP systems and processes.
• Support regulatory submissions and attend to regulatory queries in a timely manner.
• Uphold Pfizer's code of conduct and values.
• Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations. Develop courses of action and drive implementation of solutions.
• Collaborate with cross-functional teams to drive flawless execution.
• Delegate for Senior QA Manager in his/her absence.
• Mentor members (including interns) within the Quality Assurance team.
• Actively participate in Safety initiatives, and perform investigation related to EHS (as needed).

Job Related Requirements:

• Demonstrate ability to act decisively and independently to resolve issues.
• Strong verbal, written communication and presentation skills.
• Demonstrated ability to perform in a team and provide mentorship to team members.
• Possess a can-do / pride to succeed attitude and be a positive influencer/role model.
• Embrace the use of digital technology to scale and speed up every form of interaction and action.

Education And Experience

• Degree in Chemistry, Microbiology, Engineering or other Science related discipline.
• Minimum 8 years experience (including Quality Assurance roles) within the pharmaceutical industry.
• Compliance, regulatory or validation (process and /or cleaning) experience is an advantage.
• Strong written and oral communication skills. Technical report writing skills is an advantage.
• Demonstrated personal leadership, accountability, and organizational skills with proven ability to operate independently with minimal supervision. Experience working in a cross-functional, matrix environment is an advantage.

Additional Information
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


Tags
lead qa specialist lead qa specialist