Divisional Supplier QA Manager
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Job Location:
Monthly Salary:
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
Primary Job Function:
Supports implementation of strategy at suppliers ensuring compliance is maintained and business needs supported. Any areas of risk to product quality patient safety or market supply are managed directly by this position including establishment and execution of appropriate actions and communication to senior leadership.
Provide QA activities for suppliers ensuring compliance to applicable regulatory requirements and Quality Agreements and in co-operation with all relevant functions.
Lead the quality related activities at Suppliers producing divisional products on behalf of Abbott to ensure safe efficacious and quality product can be supplied in accordance with regulatory and business requirements.
To ensure that divisional suppliers maintain compliance to applicable regulatory requirements and Quality Agreements.
Provide expertise to site supplier QA to drive best practices across Division.
Core Job Responsibilities:
Develop and consistently execute a quality strategy for divisional suppliers to assure business objectives are met while assuring compliance to applicable regulatory requirements and Abbott policies.
To ensure that the commitments of the Quality Agreements are being fulfilled and help facilitate resolution in cases where they are not.
Support to complete goals with cross-functional/divisional scope ensuring alignment with EPD business strategy.
Participate on QA cross-functional teams to support suppliers including active participation in Business Management Reviews as necessary.
Represent QA in strategic business meetings and communicate with senior management.
Assure compliance of all divisional products & materials manufactured at suppliers.
Act as the quality review for significant supplier exception events for impact on product quality safety efficacy and impact to the regulatory filing.
Develop and maintain an appropriate Quality Management Review program and Quality Performance Measurements for Suppliers which identify and address quality operational and organizational issues.
Provide QA expertise to internal and cross-functional teams.
Provide expert knowledge on all relevant regulations and standards and maintain such knowledge current.
Act as QA SME in cross-functional and cross-divisional project teams working with other functions including pharmacovigilance regulatory commercial divisional product protection to integrate Quality strategy.
Promote continuous improvement innovation simplification aligned with Abbott and EPD strategy.
Embed and drive appropriate risk-based decision making.
Preparation & maintenance of Audit preparation and Supplier Ownership change form.
Management of Supplier Performance Monitoring
Management of Quality Technical agreement with suppliers.
Management of Supplier change notifications.
Support in Alternate Supplier Development
Management of Approved supplier list
Supervisory/Management Responsibilities:
Direct Reports: 0
Indirect Reports: 0
Position Accountability/Scope:
This position is responsible and accountable for:
Providing QA expertise for divisional suppliers that produce global products for EPD.
Ensuring that divisional suppliers maintain compliance with the Quality Agreements and local and international regulations as required by markets supplied and ensuring that the quality systems are appropriate so that the product safety efficacy and quality are maintained.
Decision making as it pertains to quality issues for products manufactures at suppliers impacting EPD business and strategy.
Minimum Education:
M Pharma in Pharmaceutics
B- Pharma
Post Graduate Diploma in Regulatory Affairs.
Minimum Experience/Training Required:
Total combined years: 8 in QA Operations or Pharmaceutical
Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Testing Operations.
Knowledge of international and local quality system and compliance legislations and standards including but not limited to pharma.
Excellent verbal and written communication skills in Business English.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
EPD Established Pharma
LOCATION:
India > Mumbai : BKC Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Required Experience:
Manager
Key Skills
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
