Job Description

POSITION SUMMARY

The incumbent is member of the Quality Control (QC) System team. Under the supervision of the QC (System) Manager, the incumbent will be responsible for the Quality Control operational or system aspects of all analytical testing within the QC Laboratory. The incumbent will be responsible for leading, coaching and developing the QC chemists and analysts and ensuring appropriate laboratory support in terms of equipment availability, gLIMs & Empower readiness is provided to the QC Operation team in a safe and reliable manner to support manufacturing operations. The incumbent will ensure that the quality systems in the laboratory, Good Laboratory Practices (GLPs), Good Documentation Practices (GDPs) and all related operations observe consistent compliance with Good Manufacturing Practices (GMPs), Pfizer Quality Standards (PQS) policies, site Standard Operating Procedures (SOPs)

Core Competencies:

• Good Interpersonal Skills
• Team Leadership
• Good Organisational Skills
• Good Communication Skills
• Good Report writing
• Good Analytical Skills

POSITION RESPONSIBILITIES

• Write, approve and review working procedures for the laboratory.
• Conduct laboratory investigations and ensure all follow up actions are completed Make decisions based on scientific and logical reasoning on behalf of the QC (system) manager when required.
• Supervise QC personnel in troubleshooting laboratory equipment failure and laboratory investigation.
• Train fellow colleagues on written procedures pertaining to equipment operation and general laboratory operation.
• Conduct training to increase staff knowledge and understanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements, product chemistry and sophisticated laboratory equipment.
• Participate and lead site teams/projects e.g. LIMS, CDS, Safety, continuous improvement, Analytical Method Transfer Exercise.
• Supervise the team of chemist & analyst and ensure that timely support is provided to the site (e.g. gLIMs master data creation / modification, Empower customize report, PM/Cal and validation of QC equipment, periodic DI evaluation). Ensure analyst follow the ALCOA principles.
• Work closely with key QA, Production, Engineering and EHS personnel to support them in any trouble-shooting when required.
• Help to manage the budget of the laboratory expenses.
• Develop the skills and capabilities of QC Chemists & Analysts.
• Commitment to work and positive influencer/role model/motivate others for overall operational excellence.
• Stand in for the QC (System) Manager in his/her absence.

Job Related Requirements:

• Demonstrated leadership and customer service skills.
• Effective problem solving skills.
• Excellent verbal, written communication and presentation skills.
• Demonstrated ability to perform in a team and matrix management function.
• Demonstrated leadership and management potential, innovative and strategic thinking ability.
• Comprehensive knowledge of cGMPs and appropriate regulations.
• Comprehensive knowledge of LIMS, HPLC, GC and laboratory equipment.
• Experience in gLIMs, Empower software/ SAP will be an added advantage.

Accountability:

• QC System support (eg. gLIMs, Empower, equipment readiness).
• Staff Development.
• Performance Review.
• Laboratory Non-conformance and Investigation management.
• Laboratory safety and housekeeping
• Procedures Development & Review
• Training
• Change Control Implementation

Front Line Leaders Responsibilities :

• Engage and inspire their teams on performance expectations and coach the team to meet those expectations using Coaching Skill principles.
• Focus on Safety and GMP Compliance as operational priorities and as performance measures that should be included in metrics.
• Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise and coach their teams.
• Be accountable for the Good Data Management and Data integrity understanding and performance of their team.
• Effectively monitor the actions of their team. Ensure an active daily presence in the GMP work area to observe the work activity and practices within their role responsibilities.
• Be available to their direct reports for real time escalations of any concerns or support needs
• Be observant, investigate and report actions or behaviors that may negatively impact the desired outcome of the GMP process or activity.
• Be a role model to support a positive compliance culture.
• Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or Data Integrity principles.

Key Performance Indicators (KPIs):

• Safety Performance.
• New Procedures/SOPs implementation.
• Lead time for QC testing.
• Budget control.
• Project Milestones and Implementation.
• Compliance to GMP/GLP requirements.
• Timely completion of training.
• Timely laboratory investigation

ORGANIZATIONAL RELATIONSHIPS

Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.

Internal:

The incumbent will interact with all site departments for GMP related laboratory operations and activities i.e. Manufacturing Operations Process Teams, Quality Assurance, Warehouse and Tank Farm teams and Engineering teams.

External:

Vendors for instrumentation and laboratory supplies.

Supervision

The incumbent is responsible for 4-10 direct reports.

EDUCATION

Bachelor or Master or Ph.D degree in Science (Chemistry preferred) or Life Science relating to Chemistry, Pharmacy, Pharmacutical Science or Microbiology or a related science.

EXPERIENCE

For QC Supervisor:

• Not less than 5 years\xe2\x80\x99 experience working in a chemical laboratory, preferably within the pharmaceutical industry and with experience in managing/supervising small (5-7) groups of laboratory analysts.
• Additional experience in Quality Assurance is highly desirable.
• Proven track record in people management and in supervisory role
• Extensive knowledge of GMP compliance requirements for Quality Control laboratories is a must.

Work Location Assignment: Flexible

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

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Pfizer