Job Description

Why Patients Need YouEverything 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.
• 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.
• Responsible for managing the training of Quality Control laboratory personnel.
• Involved in the management of stability program and associated activities in the Quality Control laboratory.
• Support data analysis and trending of QC data for annual product record review (APRR).
• Responsible to work with cross functions to ensure completion of activities.
• Understand GMP principles in the QC laboratory and comply with Data Integrity requirements (ALCOA+)
• Ensure the audit readiness and presenting during audits as SME.

How You Will Achieve ItRelease

• 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.

Investigation

• 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.
• Support any QC related manufacturing incident report (MIR).

Training

• Conduct orientation training for the new colleagues and mentor them till they are competent to perform task independently.
• Conduct instructor lead training and refresher training
• Identify training needs and conduct/organize training to close the training gaps. Assist QC supervisors/Managers to administer Job Training Curricula of the QC analysts and chemists
• Assess training effectiveness and knowledge retention of the relevant trainings.
• Administer proper documentation for all training related forms and records \xe2\x80\x93 Learning Records, assessments, evaluations, Course Information Forms, Learning Requisitions.
• Proficient in PLA (Pfizer Learning Academy) and able to manage the training requirements of the QC Team, which includes coordinating all training activities and facilitating group training for the team.
• Monitor training completion rate and provide metrics to the QC Tier 2.
• Coordinate with other functions for internal and external training arrangement for the QC team.
• Participate in safety and quality incident investigation to identify opportunities for continuous improvement to training related gaps and human performance factors
• Plan and Schedule training for shift colleagues including their off/rest days.
• Liaising with Technical Learning and capability (TLC) to improve the training effectiveness for QC team
• Liaise with external training providers to source and organize relevant training for the QC team
• Management of regulatory inspection to present QC training system.

Stability

• Manage stability testing with different functions to ensure stability studies (Annual, validation and adhoc) are identified and promptly initiated in QC laboratory.
• Track and monitor stability samples within the QC laboratory are promptly tested and completed within the agreed timeline as per site procedures.
• Ensure all stability testing records are reviewed and trending of stability data to confirm adverse trends, stability OOS Or questionable results.
• Prepares annual stability reports and ad hoc stability reports for Annual Product Review and regulatory submission.
• Act as the Subject Matter Experts for QC for all stability related topics and manage regulatory inspection for stability related topics.
• Write and review Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory.
• Conduct investigations relating to Stability studies.
• Ensure stability testing records and all documentations related to stability 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.
• Collect and analyse QC released data and prepare reports to support the annual product record review (APRR) for the different products manufactured onsite.

Others

• To support other QC function in terms of testing and reviewing if deemed required.

QualificationsMust Have

• Degree or Diploma in Science (preferably Chemistry) or Chemical Process Technology.
• 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.
• Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations
• Knowledge of Good Manufacturing Practices and its application standards, processes and policies
• Excellent organizational skills and strong ability to multi-task
• Strong written and verbal communication skills

Nice-to-Have

• Laboratory work experience with analytical chromatographic technique
• Knowledge of lean manufacturing, six sigma methodologies, and statistics
• Experience leading continuous improvement projects

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

Pfizer