Job Description

ROLE SUMMARY:

This Pfizer Quality Operations position will support the PharmSci Small Molecules QO department by performing Quality Assurance activities associated with the analytical development and testing of clinical materials. Activities may include analytical method validation review/approval, instrument/equipment qualification, investigations, change control, SOPs and ensuring adherence to regulatory and internal compliance standards at the Pfizer Indian Institute of Technology Madras Research Park (IITMRP). The candidate will partner with key business lines to provide QA GMP guidance and support. The candidate should possess sufficient knowledge of cGMPs and have a knowledge of scientific principles.

Location: Colleague will be based in IITMRP Chennai and follow a flexible working program of onsite and remote work.

ROLE RESPONSIBILITIES & SKILL SETS:

• Responsible for review/approval of the documents pertaining to product development, analytical data review (electronic data and chromatographic data), instrument and equipment qualification.
• Responsible for ensuring data integrity (DI) and SOP compliance during review of hard copy and electronic records.
• Responsible for performing Systems audit trail periodic review and assessing 21 CFR part 22 requirements.
• Responsible for ensuring microbiology and chemistry labs compliance in day-to-day activities.
• Responsible for connecting and communicating with local and global business lines (BL) and Operations Quality (OQ) colleagues to meet objectives.
• Drive effective management of quality issues and investigations, including decisions that may involve moderately complex quality and technical issues or concepts.
• Responsible for escalation of issues through notification to manager.
• Recommends and proficiently applies quality/risk management tools in problem solving and issue resolution.
• Participate in the implementation of new initiatives and goals within QA function and with business line partners to drive consistency, efficiency, and compliance.

Skill Sets :

• Awareness on DI and ALOCA principles.
• Basic understanding cGMP requirement, such as21 CFR part 210 and 211, ICH guidelines and sterile products requirements.
• Should be able to perform statistical evaluation and analytics of analytical data during review of method development and validation.
• Should be aware of ICH quality guidelines and other regulatory guidance for microbiology method development for sterility, Bacterial endotoxin test (BET) and Container closure integrity test (CCIT) and development requirements.
• Must have good communication and influencing skills.
• Well-disciplined and self-motivated attitude.
• Manage own time to meet agreed targets and develop plans for work activities on own projects within assigned teams.
• Suggest improvements and conduct continuous improvement activities.
• Contribute to the development and compliance of quality and business line partner procedures.
• Provide support to Inspection Readiness efforts, internal audits & regulatory inspections as needed. Must have good command on Microsoft office operation -Excel, Word and PowerPoint presentation preparation.
• Good understanding of risk management methodologies.

Desirable skills: Digital skill set and experience with advanced data analytics/visualizations (e.g., Spotfire, Tableau, MS Power Business Intelligence).

QUALIFICATIONS :

Education:

Master of science in chemistry

Master of pharmacy in QA or chemistry

Relevant experience:

Relevant work experience in an analytical development, analytical QA and Quality control laboratory and/or

cGMP pharmaceutical manufacturing area.

PHYSICAL/MENTAL REQUIREMENTS :

Should be able to perform the data analysis and shall bring outcome /discussion and way forward for improvements with QA leads and BL .

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS :

No frequent travel, only as and when needed for Business.

This position is an individual contributor role and does not include the management of direct reports.

ORGANIZATIONAL RELATIONSHIPS:

This role will have direct interaction and coordination with Cross functional team locally, globally and within PSOQ function.

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