9 days old

Quality Systems Lead

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**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**

You will be a member of Pfizer's dedicated and highly effective quality assurance team. You will evaluate and review Pfizer's clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.

**How You Will Achieve It**

+ Lead Supplier Management System for qualification and certification of all suppliers and vendors.

+ Develop and maintain Vendor Audit Program and effectively driving improvement in GMP and quality culture

+ Ensure Third Party Operations Quality Oversight involved for the toll manufacturing of Pfizer Products.

+ Lead Artwork Management through ePALMS System and Ensure timely development of artworks.

+ Ensure that Artwork of all printed packaging components is developed, approved and comply with Pfizer/local regulatory requirements.

+ Lead Quality Risk Management at the site and ensure that effective Risk Management system is in place in accordance with Pfizer Quality Standards.

+ Lead APRR program and ensure that recommendation made in Annual Product Record Review have been implemented.

+ Lead Document Control System and ensure timely issuance of compliance documents to relevant stakeholders. Act as QA for Computer Systems.

+ Review and Approve Documents in PDOCS.

+ Manage multiple projects and ongoing work activities within the division typically involving cross-functional representatives.

+ Manage the specific Inspection preparation plan for key Good Manufacturing Practices {also cGMP} elements etc.

+ Provides guidance and coaching to Quality Operations colleagues and provide direction or approval of activities and decisions.

+ Provide Quality Assurance expertise to site and external parties as required.

+ Identify continuous improvement opportunities based on metrics and drive consistency through the process to align with Pfizer's standard processes and quality systems.

+ Manage site prioritization and management escalation meetings regarding AQRTs (Area Quality Review Teams).

+ Assist in key site quality behavior establishment, set clear company policies and behavior expectation for team member.

+ Prepare departmental budgets and control the departmental cost within the budgets.

+ Interface with Regulatory Agencies in audits, track and report metrics for all internal auditing activities.

+ Manage and monitor the audit report distribution process to ensure timely delivery of critical information to key stakeholders and complete regulatory commitments

+ Take independent actions and decisions and motivate key stakeholders to deliver quality outcomes for business requirements.



+ Master of Science/Pharm-D

+ Minimum 3 year experience on Managerial position in Quality Operations. Overall atleast 7 year experience in Pharmaceutical industry.

+ Working knowledge of current Good Manufacturing Practices {cGMP} for a pharmaceutical industry

+ Extensive knowledge of corporate quality systems that are applicable to the quality unit and the production operations serviced

+ Strong collaboration, relationship management, and interpersonal skills

+ Strong people management experience

+ Excellent written and oral communication skills

+ Strong computer proficiency skills in MS Office, Word, Excel, Access, Project, Trackwise or equivalent


+ Certified Lead Auditor

+ Knowledge ofpharmaceutical industry regulations

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

Posted: 2021-06-11 Expires: 2021-07-12
Sponsored by:
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