Associate Quality Complaints Job at Amgen (Hyderabad)

Sr. Associate Quality Complaints

Amgen is seeking a Sr Associate Quality Complaints owner and member of the Produ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree
OR Bachelor’s degree and 2 years of Quality experience
OR Associate’s degree and 6 years of Quality experience
OR High school diploma / GED and 8 years of Quality experience
Fluency in verbal and written English to be able to understand & articulate technical concepts

Job Responsibility

Conducts low to medium complexity complaint investigations and determines if complaint investigations require escalation for further investigation
Evaluates and ensures triaged product complaint records comply with applicable procedures
Evaluates and owns complaint records with basic investigations
Ensures quality of complaint records
Completes assigned assessments per applicable procedures
Applies analytical skills to evaluate complex situations using multiple sources of information
Executes the complaint process per SOP requirements
Owns or manages the review/approval process flow in CDOCS of controlled documents
while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guide
Supports management of assigned projects or project tasks to achieve agreed deliverables within time and with expected quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance

Fulltime

Senior Associate, Quality Complaints

Join Amgen’s Mission of Serving Patients. In this vital role you will own and im...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree and 4 to 7 years of Quality experience
Bachelor’s degree and 5 to 9 years of Quality experience
Quality and/or manufacturing experience in biotech, medical device or pharmaceutical industry
Bachelor’s Degree in a Science Field
Ability to successfully manage workload to timelines
Familiarity with basic project management tools
Ability to operate in a matrixed or team environment with site, functional, and senior management leadership
Experience in driving decision making by using the DAI principles
Understanding of quality and industry requirements/expectations of a QMS
Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

Job Responsibility

Own and implement the end-to-end global complaint process and management system
Ensure complaint processes and systems remain fully compliant through the quality operating standards and procedures
Translate information from the market to drive continuous improvement
Conduct low to medium complexity complaint investigations
Determine if complaint investigations require issue for further investigation
Evaluate and ensure triaged product complaint records align with applicable procedures
Evaluate and own complaint records with basic investigations
Ensure quality of complaint records
Complete assigned assessments per applicable procedures
Apply analytical skills to evaluate sophisticated situations using multiple sources of information

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Associate Quality Assurance (Incoming QA)

As Associate Quality Assurance, you will be part of the Incoming QA team, playin...

Location

Netherlands , Breda

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

MBO or Bachelor's degree in Life Sciences or a related field, or an equivalent combination of education and experience
Preferably around three years of experience within the pharmaceutical industry or a regulated environment
Working knowledge of Good Manufacturing Practice (GMP) and/or Good Distribution Practice (GDP), with the ability to interpret and apply requirements in routine situations
Strong attention to detail, structured way of working, and a quality-first mindset
Fluency in English, both written and spoken

Job Responsibility

Execute sampling and inspection of incoming materials, including commercial and clinical printed and non-printed packaging components and devices
Perform review and release of incoming materials in accordance with applicable procedures and quality requirements
Collect data and initiate follow-up with internal stakeholders (e.g. Warehouse, Supply Chain, External Supply) and/or Amgen suppliers to resolve quality issues
Initiate, document, and own minor deviations, ensuring timely investigation and closure
Perform reserve sample inspections to support product complaint investigations, deviations, or the annual reserve sample inspection process
Execute additional sampling, inspection, and damage assessment of received components as required

What we offer

Full support and resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising competitive salary, bonus structure, fixed 13th month, holiday allowance and a collective health insurance
Focus on vitality with an on-site gym, vitality program and a restaurant with healthy food

Fulltime

Associate Quality Assurance (PQA)

The candidate will be responsible for providing oversight for Quality on-the-flo...

Location

Singapore , Tuas

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s Degree and 2 years of directly related experience
Associate’s Degree and 4 years of directly related experience
High School Diploma / GED and 6 years of directly related experience
1-3 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical/biopharmaceutical industry
Direct experience with bulk manufacturing of biopharmaceuticals preferred
Demonstrated proficiency of written and verbal communication skills
Ability and willingness to work any shift in support of operations that may include 24/7

Job Responsibility

Provide oversight for Quality on-the-floor and operations support
Support manufacturing operations and IPC testing through purposeful presence on the floor
Support complex manufacturing investigations, change control, and unexpected result investigations
Perform 12-hour shift (day/night)
Support the maturation and continuous improvement of Amgen quality systems
Participate in root cause investigations for non-conformances
Review nonconformance investigations, change controls, and other quality records
Support in regulatory inspections, and interact directly with regulatory inspectors
Support other QA initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Medical check expenses borne by the company

Fulltime

Quality Associate

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Canada , Alliston

Salary:

72080.00 - 108120.00 CAD / Year

Baxter

Expiration Date

Until further notice

Requirements

University Degree, Bachelor of Science - Microbiology, Chemistry, Biological Sciences, Engineering / ASQ certification, other Quality Certification preferred or Combined Equivalent in Work Experience
Minimum 3 Years of experience required
Manufacturing and quality background
Previous experience in a GMP environment
Knowledge of cGMP, ISO, and Regulatory standards
Detail oriented with the ability to work under pressure
Strong written and oral communication skills, negotiation skills, ability to work with all levels of the organization
Ability to build strong relationships and partner with internal and external stakeholders
Strong ability to balance multiple priorities
Strong analytical and problem-solving skills with critical thinking abilities

Job Responsibility

Provide front line day to day support on product quality issues to ensure GMP, regulatory and procedural compliance to maintain high standards of quality
Support on assigned shift, with requirement to support plant overtime and planned shutdowns when applicable
Provide technical support on review/approval of department related procedural changes product quality issues, reinspection, new product introduction and Protocols
Partner with Quality and Production personnel to ensure mitigating actions are identified and implemented
Support timely follow-up on quality exceptions and their preventative/corrective actions
Support initiation/investigation and approvals of non-conformance events in the Trackwise system
Support release process by performing final release of products to distribution by ensuring product conforms to specifications, SOPs and regulatory requirements
Support Quality IT Systems
Ensure control of defective WIP materials to ensure adequate segregation, movement, documentation and timely follow-up within the plant to comply with Regulatory and Compliance requirements
Ensure shop floor presence by performing process walkabouts and supporting operations to remediate issues that are identified

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Quality Associate

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Canada , Alliston, Ontario

Salary:

72080.00 - 108120.00 CAD / Year

Baxter

Expiration Date

Until further notice

Requirements

University Degree, Bachelor of Science - Microbiology, Chemistry, Biological Sciences, Engineering / ASQ certification, other Quality Certification preferred or Combined Equivalent in Work Experience
Minimum 3 Years of experience required
Manufacturing and quality background
Previous experience in a GMP environment
Knowledge of cGMP, ISO, and Regulatory standards
Detail oriented with the ability to work under pressure
Strong written and oral communication skills, negotiation skills, ability to work with all levels of the organization
Ability to build strong relationships and partner with internal and external stakeholders
Strong ability to balance multiple priorities
Strong analytical and problem-solving skills with critical thinking abilities

Job Responsibility

Provide front line day to day support on product quality issues to ensure GMP, regulatory and procedural compliance to maintain high standards of quality
Support on assigned shift, with requirement to support plant overtime and planned shutdowns when applicable
Provide technical support on review/approval of department related procedural changes product quality issues, reinspection, new product introduction and Protocols
Partner with Quality and Production personnel to ensure mitigating actions are identified and implemented
Support timely follow-up on quality exceptions and their preventative/corrective actions
Support initiation/investigation and approvals of non-conformance events in the Trackwise system
Support release process by performing final release of products to distribution by ensuring product conforms to specifications, SOPs and regulatory requirements
Support Quality IT Systems (SPC Infinity, EBR, BMTCS, etc.)
Ensure control of defective WIP materials (quarantine, retention and disposal areas) to ensure adequate segregation, movement, documentation and timely follow-up within the plant to comply with Regulatory and Compliance requirements
Ensure shop floor presence by performing process walkabouts and supporting operations to remediate issues that are identified

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Senior Associate Quality Assurance

Part-time job: 30 hours/week. CW position - via personnel agency. Employment con...

Location

Czech Republic , Prague

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

University Degree in Pharmacy, Chemistry or Medicine
Fluency in Czech and English languages

Job Responsibility

Ensures adherence to EU GDP requirements and the Czech regulations in relation to Wholesale Distribution
Maintains Quality Management System at the affiliate level in compliance with Czech regulations and Amgen standards
Performs Quality-related activities for Czech market
Supports regional activities to maintain quality system and executes tasks in compliance with Amgen’s Quality Management System, GMP & GDP requirements and any local applicable regulations
Supports QA Manager and Responsible Person to ensure that Quality Management System is implemented and maintained in compliance with the requirements of the EU GDP and applicable regulations in Czech Republic
Ensures that documentation is accordingly processed, records are accurate and up to date and kept according to applicable requirements
Ensures personnel involved in GDP activities are adequately trained
Supports handling of Product Complaints, identification of Adverse Events, Medical Information enquiries and brand protection issues as well as potential counterfeit
Supports authority inspections, audits, and self-inspections
Makes the disposition decision of the medicinal products (including product release) to Czech market

Parttime

Quality Assurance Associate

DCBL is a highly successful business and are one of the market leaders in Debt C...

Location

United Kingdom

Salary:

28000.00 GBP / Year

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Familiarity and competency using Microsoft Office (Word, Excel, Outlook) is essential for effective reporting and communication
Excellent verbal and written communication skills, with a strong ability to produce reports, present findings, and deliver feedback
Strong time management skills to manage multiple priorities efficiently and meet deadlines
Ability to work flexibly and adapt to changing circumstances
High attention to detail to ensure the accuracy and compliance of all processes
Ability to solve problems, be proactive and make decisions effectively
Ability to work as part of a team and alone
Ability to multitask in a fast-paced office environment

Job Responsibility

Conduct regular quality monitoring reviews across all business areas to assess the effectiveness of communications and processes
Identify best practice and areas of concern, providing feedback and findings to relevant stakeholders
Analyse results from quality monitoring, identify recurring issues or themes, and determine the root causes
Collaborate with relevant teams to design corrective action plans to improve overall quality
Identify training needs based on the findings from quality reviews and liaise with operational managers and the training department to ensure support is provided to the necessary teams to improve performance
Work closely with the Operational teams to ensure internal processes align with regulations and company standards
Regularly review and update these processes to ensure ongoing compliance
Monitor and assess adherence to customer and regulatory requirements, including identifying data breaches, ensuring objection handling is effective and complaints are managed according to company protocols
Log and report outcomes and trends identified through QA reviews
Conduct detailed root cause analysis and engage with stakeholders to implement necessary improvements

What we offer

Early finish Fridays
Dress Down Fridays
30 days holiday (including Bank Holidays)
Employee Assistance Programme
Newly refurbished offices
Free Mersey Gateway bridge pass
Free parking
Free tea and coffee facilities
Free monthly lunch
Company social events

Fulltime

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Associate Quality Complaints

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