Qc Chemist

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- The incumbent will be responsible for QC sample approval/lot disposition in the Quality Control laboratory.- Work with the different QC team functions to ensure products are tested and released within the agreed Service Level Agreement.- Involved in capacity planning and work forecast to ensure optimal efficiency in resources utilization.- Responsible for conducting Laboratory Investigation on Out of Specification / Questionable QC test results and deep dive for root cause determination and effective Corrective Action and Preventive Action (CAPA) implementation.- Understand GMP principles in the QC laboratory and comply with Data Integrity requirements (ALCOA+)

How You Will Achieve It- Performs quality review of completed test records, approval of QC samples/lot disposition in the Laboratory Information Management System (LIMS) and release of API, Intermediates, raw materials, solvents, and packaging materials.- Ensure prompt approval of QC samples as per Service Level Agreement for the different products and escalate any potential delay to the different cross functions.- Involved in QC testing capacity model with other QC team functions to forecast incoming samples for all materials against available capacity and to highlight any constraints to management.- Generate reports on schedule adherence and other KPIs to overall QC operational efficiency.- Represent QC in cross functional meeting to ensure products (API, intermediates, and RM) required are incorporated into QC operational testing schedule.- Represent QC in New Product Introduction meeting to ensure all operational issues noted are escalated and resolved.- Write and review Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory.- Ensure all documentations and quality records are conducted in accordance to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements and that they are filed in accordance to existing policies.- Participate actively and contribute to site project teams.- Train fellow colleagues on written procedures and SOPs pertaining to QC sample approval/lot disposition in the Quality Control laboratory.- Provide data for the budgeting process including justification for manpower changes.- Conduct laboratory investigations and ensure all follow up actions are completed.- To get qualified on using Method 1 tools (5 WHYS, Fishbone, etc.) and be PHP trained to support laboratory investigation writeup.- To familiarize and get qualified on associated technical investigation writing training modules to support investigation write up and conduct effective training to new investigator if necessary.- To prepare and generate relevant reports associated to investigation for Laboratory Investigation Report (LIR) trending and for proactive monitoring purposes.- Ensure the audit readiness and presenting during audits as SME.

**Qualifications**:
- For a Diploma: A minimum of 5 years QC experience in the pharmaceutical or related industry.- For a Degree: A minimum of 3 years QC experience in the pharmaceutical industry.

Job Related Requirements- Demonstrated leadership and customer service skills.- Effective problem solving skills.- Strong verbal, written communication and presentation skills.- Demonstrated ability to perform in a team.- Comprehensive knowledge of cGMPs and appropriate regulations.- Experience in Empower software/ SAP will be an added advantage

Work Location Assignment: On Premise

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