Manager, C&Q Document Preparation (Drug Product) Job at Amgen (Hyderabad)

Manager, C&Q Document Preparation (Finished Drug Product / Packaging)

In this vital role, you will lead the preparation and delivery of commissioning ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in engineering, Life Sciences, Pharmaceutical Sciences, or a related technical field
8-13 years of experience in GMP commissioning, qualification, validation, engineering, or technical operations within the pharmaceutical or biotechnology industry
Experience supporting commissioning and qualification activities for manufacturing systems, packaging equipment, or facilities and utilities
Experience preparing or overseeing qualification documentation including protocols, reports, risk assessments, traceability matrices, and testing documentation
Experience working in regulated GMP manufacturing environments with knowledge of inspection readiness and compliance expectations
Strong understanding of GMP commissioning, qualification, and validation practices within regulated pharmaceutical or biotechnology environments
Experience leading technical teams including full-time employees and contingent or outsourced resources
Strong understanding of risk-based qualification methodologies and lifecycle validation approaches
Knowledge of GMP documentation practices, data integrity expectations, and inspection readiness principles
Experience collaborating across Engineering, Validation, Quality, Manufacturing, Facilities, and Project Management teams

Job Responsibility

Lead a team responsible for preparation and delivery of C&Q documentation supporting commissioning and qualification activities across Engineering projects and systems
Manage work across a blended team of employees and contingent resources, ensuring effective planning, prioritization, and execution of deliverables
Oversee development of qualification protocols, reports, risk assessments, traceability matrices, and related qualification documentation
Execute C&Q documentation preparation using established CoE standards, templates, and processes to ensure consistency, compliance, and efficiency
Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Project teams to support qualification execution and operational readiness activities
Monitor documentation progress, identify risks, and drive timely resolution of issues that may impact project timelines
Maintain inspection-ready documentation and support regulatory inspections and internal audits as required
Support implementation of standardized C&Q practices, templates, and procedures across Engineering projects and sites
Provide leadership, coaching, and development for team members while fostering a culture of accountability, collaboration, and quality execution
Contribute to continuous improvement initiatives that enhance C&Q documentation quality, efficiency, and compliance

Fulltime

Continuous Improvement Lead – Commissioning & Qualification

Amgen is seeking a Continuous Improvement Lead – Commissioning & Qualification (...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelors or Masters degree
8-13 Years of work experience in the relevant field
Experience implementing or supporting digital transformation initiatives within Engineering, Validation, or Technical Operations environments
Knowledge of ASTM E2500, ISPE guidance, or modern risk-based commissioning and qualification approaches
Experience driving cross-site or global process standardization initiatives
Experience in GMP commissioning, qualification, validation, or technical operations in a regulated pharmaceutical or biotechnology environment
Experience implementing or supporting Kneat or other electronic validation / digital documentation platforms
Experience leading continuous improvement, digital enablement, or process standardization initiatives across engineering or technical operations programs
Experience developing metrics, dashboards, or reporting tools using PowerBI, Tableau, Smartsheet, or similar analytics platforms
Strong understanding of risk-based qualification methodologies and lifecycle validation approaches

Job Responsibility

Lead continuous improvement initiatives focused on C&Q document preparation, digital C&Q execution, and process standardization
Establish and maintain governance for C&Q digital tools, documentation standards, and continuous improvement initiatives across Engineering projects and sites
Drive optimization, governance, and adoption of Kneat and other digital validation tools across Engineering projects and manufacturing sites
Develop and maintain standardized templates, workflows, and best practices supporting digital commissioning and qualification execution
Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Digital Technology teams to identify and implement process and technology improvements
Establish and monitor performance metrics and reporting to measure efficiency, documentation quality, and program effectiveness
Analyze operational data and program metrics to identify opportunities to improve efficiency, compliance, and execution consistency
Lead implementation and adoption of standardized C&Q practices, templates, and procedures across Engineering projects and sites
Provide training, coaching, and user support for Kneat and other digital tools used in C&Q execution
Ensure digital processes and documentation practices align with GMP requirements, data integrity standards, and regulatory expectations

New

KidStrong Assistant General Manager

KidStrong Assistant General Managers are the second in command when it comes to ...

Location

United States , Cedar Rapids

Salary:

40000.00 - 45000.00 USD / Year

KidStrong Henderson

Expiration Date

Until further notice

Requirements

Athletic or coaching background with experience working with or coaching kids ages 15 months - 11 years old - a passion for working with children is non-negotiable! Comfortable speaking to parents/guardians regarding a variety of topics
Achieve Coach Certification through the HQ Training and Certification team
Complete training through LearnUpon as required by the HQ Training and Certification team
Prior experience as a pediatric OT/PT is a plus, but not required
Previous experience in management is preferred but not required
Practical work experience with Google and Microsoft platforms
Previous experience with systems and platforms such as ZenPlanner, LearnUpon, CareerPlug, and ADP is preferred but not required
Intermediate knowledge of physiology, exercise techniques, and body mechanics
CPR certified

Job Responsibility

Understand the center's key KPIs and financials to make informed and responsible business decisions
Build and maintain relationships with KidStrong families to align with our core values and provide exceptional customer service
Oversee center initiatives i.e. center maintenance, training, brand consistency, etc.
Daily, Weekly, and Monthly cleaning and maintenance of the center
The typical schedule includes 4 weekdays and 1-weekend shift with specific hours dependent on the needs of the center
Communicate any Coach schedule changes using appropriate scheduling and communication platforms
Sell and schedule events such as camps and parties, to maximize center profitability
Maintain flawless lead management by conducting call drives to new and existing leads in the Center's CRM tool
Finalize sales and bookings that are generated through online self-sign-up flow
Source and attend local events to increase brand awareness, and drive incremental leads and memberships

Fulltime

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Assistant General Manager / Coach

At KidStrong, we help parents build smarter, stronger, more athletic kiddos with...

Location

United States , Hamden

Salary:

55000.00 - 67000.00 USD / Year

KidStrong Henderson

Expiration Date

Until further notice

Requirements

Experience working with kids (education, coaching, fitness, etc.)
Sales & leadership experience preferred
Associate or Bachelor’s degree in Business, Education, or related field a plus
Strong communication, organization, & multi-tasking skills
Tech-savvy: Comfortable using Microsoft Office
CPR & First Aid Certified
EpiPen Certified

Job Responsibility

Drive membership growth & sales
Lead an engaged, high-energy team
Create a fun & positive environment for kids and parents
Coach 8-12 KidStrong classes per week
Provide inspirational leadership to coaches & staff
Assist the GM in meeting sales & operational goals
Maintain class scheduling & optimization
Ensure exceptional customer service and member retention
Teach high-energy, pre-designed KidStrong workouts (ages walking – 11 years old)
Motivate and engage with parents & students

What we offer

Health insurance
Opportunity for advancement
Paid time off
Training & development
Wellness resources
401(k)
Bonus based on performance
Competitive salary
Dental insurance
Employee discounts

Fulltime

New

General Manager

KidStrong General Managers are the leaders of the center – it is the responsibil...

Location

United States , Tempe

Salary:

60000.00 - 80000.00 USD / Year

KidStrong Henderson

Expiration Date

Until further notice

Requirements

An athletic and/or coaching background with experience working with or coaching kids ages 15 months - 11 years old - a passion for working with children is non-negotiable!
Achieve Coach Certification through the HQ Training and Certification team
Complete training through LearnUpon as required by the HQ Training and Certification team
Comfortable speaking to parents/guardians regarding a variety of topics
Previous experience in management is required
Practical work experience with Google and Microsoft platforms
Intermediate knowledge of physiology, exercise techniques, and body mechanics
CPR certified

Job Responsibility

Understand the center's key KPIs and financials to make informed and responsible business decisions
Build and maintain relationships with KidStrong families that align with our core values and provide exceptional customer service
Oversee center-level initiatives i.e. center maintenance, training, brand consistency, etc.
Daily, Weekly, and Monthly cleaning and maintenance of the center
Manage center-level employee issues and manage appropriate documentation
Set and communicate coach schedules using appropriate scheduling and communication platforms
Schedule, promote, and sell KidStrong events, such as camps and parties, to maximize center profitability
Maintain flawless lead management by conducting call drives to new and existing leads in the Center's CRM tool
Responsible for sales, as well as delegating responsibilities to the center staff team
Finalize sales and bookings that are generated through online self-sign-up flow

What we offer

Bonus based on performance
Competitive salary
Dental insurance
Employee discounts
Flexible schedule
Free uniforms
Health insurance
Opportunity for advancement
Paid time off
Training & development

Fulltime

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Kidstrong Kids Coach

At KidStrong, we help parents build stronger, smarter, more athletic kids. Our p...

Location

United States , Summerlin

Salary:

18.00 - 22.00 USD / Hour

KidStrong Henderson

Expiration Date

Until further notice

Requirements

Experience coaching students within the appropriate KidStrong age
Experience talking to and educating parents on our curriculum
Intermediate knowledge of physiology, exercise technique, and body mechanics
CPR certified
Positive, motivating, and effective interpersonal communication skills
Self-starter that just gets a job done

What we offer

Employee discounts
Flexible schedule
Free food & snacks
Free uniforms
Opportunity for advancement
Training & development

Parttime

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Kids Coach

At KidStrong, we help parents build stronger, smarter, more athletic kids. Our p...

Location

United States , Phoenix

Salary:

18.00 - 22.00 USD / Hour

KidStrong Henderson

Expiration Date

Until further notice

Requirements

Experience coaching students within the appropriate KidStrong age
Experience talking to and educating parents on our curriculum
Intermediate knowledge of physiology, exercise technique, and body mechanics
CPR certified
Positive, motivating, and effective interpersonal communication skills
Self-starter that just gets a job done

What we offer

Employee discounts
Flexible schedule
Free food & snacks
Free uniforms
Opportunity for advancement
Paid time off
Training & development

Fulltime

New

Kidstrong Full Time Lead Coach

At KidStrong, we help parents build stronger, smarter, more athletic kids. Our p...

Location

United States , Annapolis

Salary:

20.00 USD / Hour

KidStrong Henderson

Expiration Date

Until further notice

Requirements

Experience coaching students within the appropriate KidStrong age
Experience talking to and educating parents on our curriculum
Intermediate knowledge of physiology, exercise technique, and body mechanics
CPR certified
Positive, motivating, and effective interpersonal communication skills
Self-starter that just gets a job done

What we offer

Health insurance
Vision insurance
Dental insurance

Fulltime

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Manager, C&Q Document Preparation (Drug Product)

Job Description

Job Responsibility

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