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

IT Training Lead

The IT Training Lead will drive technology learning and user adoption across the...

Location

United States , Delray Beach

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Experience in IT training, instructional design, technical enablement, or learning and development
Strong knowledge of Microsoft 365
Excellent communication, facilitation, and content development skills
Ability to translate technical concepts into practical, user-friendly training.

Job Responsibility

Design, develop, and deliver IT training programs in instructor-led, virtual, and self-paced formats
Take lead in the Microsoft Copilot and AI training strategy, including onboarding, advanced use cases, responsible AI usage, and ongoing enablement
Partner with IT leadership to support new technology rollouts, system upgrades, and digital transformation initiatives
Create and maintain training content, including videos, guides, tutorials, and job aids
Identify skill gaps and develop targeted learning solutions to improve adoption and productivity
Gather feedback and measure training effectiveness to continuously improve programs.

New

K Kitchen Representative

The position includes, but is not limited to, the following essential job duties...

Location

United States , New Albany

Salary:

Not provided

Circle K

Expiration Date

Until further notice

Requirements

Excellent communication skills
Team player who can work well with others or independently
Acts with integrity
keeps commitments
Contagious positive attitude
Focuses on achieving results while having fun
Frequently bend, twist at waist, kneel, squat, stand, and walk
Occasionally climb and descend ladders
Tolerate extreme cold and hot temperatures and work in and around fryers, ovens, grills, coolers, freezers, sharp objects, and loud noises
Reach, grasp, and manipulate objects with hands for entire shift, including reaching for objects overhead

Job Responsibility

Provides excellent guest service in a fast and friendly manner
Maintains a clean restaurant environment by cleaning and performing general housekeeping duties
Prepares and serves food items in accordance with all Brand, Company, and health department regulations
Ensures product quality, food safety, and operational standards are met
Keeps accurate cash, sales, and inventory control records
Follows all government laws and safety codes
Completes reports on all incidents following our 5-minute rule policy
Lives our Company values: One Team, Do the Right Thing, Takes Ownership, Play to Win

What we offer

Medical, Dental, Vision, Term Life and AD&D plans
Flexible spending and health savings accounts (FT)
Vacation paid time off
Company holidays paid at time and a half
Matching 401(k)
Tuition Reimbursement
Stock Purchase Plan
Employee Discount Program
Discount Meal Benefit
Wellness Plan

New

K Kitchen Representative

Location

United States , Decatur

Salary:

Not provided

Circle K

Expiration Date

Until further notice

Requirements

Excellent communication skills
Team player who can work well with others or independently
Acts with integrity
keeps commitments
Contagious positive attitude
Focuses on achieving results while having fun
Frequently bend, twist at waist, kneel, squat, stand, and walk
Occasionally climb and descend ladders
Tolerate extreme cold and hot temperatures and work in and around fryers, ovens, grills, coolers, freezers, sharp objects, and loud noises
Reach, grasp, and manipulate objects with hands for entire shift, including reaching for objects overhead

Job Responsibility

Provides excellent guest service in a fast and friendly manner
Maintains a clean restaurant environment by cleaning and performing general housekeeping duties
Prepares and serves food items in accordance with all Brand, Company, and health department regulations
Ensures product quality, food safety, and operational standards are met
Keeps accurate cash, sales, and inventory control records
Follows all government laws and safety codes
Completes reports on all incidents following our 5-minute rule policy
Lives our Company values: One Team, Do the Right Thing, Takes Ownership, Play to Win

What we offer

Medical, Dental, Vision, Term Life and AD&D plans
Flexible spending and health savings accounts (FT)
Vacation paid time off
Company holidays paid at time and a half
Matching 401(k)
Tuition Reimbursement
Stock Purchase Plan
Employee Discount Program
Discount Meal Benefit
Wellness Plan

New

Restaurant Assistant Manager

This position assists the Restaurant Manager (RM) with daily operations of the r...

Location

United States , Holly Springs

Salary:

Not provided

Circle K

Expiration Date

Until further notice

Requirements

Full time required
availability during all hours of operation and at least one hour pre-opening and post-closing required
Valid state Driver's License required
Excellent communication skills
Motivates, coaches, and leads team members
Acts with integrity
keeps commitments
Contagious positive attitude
Focuses on achieving results while having fun
Ability to gain control during stressful situations

Job Responsibility

Assists the Restaurant Manager with daily operations of the restaurant and supervises the team in their absence
Leads and coaches Restaurant Team Members and partners with the management team to maintain the Company and Brand operational standards
Provides excellent guest service in a fast and friendly manner
coaches and corrects team
Conducts second interviews for team members and shift leads
Maintains a clean restaurant environment by cleaning and performing general housekeeping duties
Assigns shift duties to team members and follows up to ensure completion
Directs team and ensures all food items are prepared and served in accordance with all Brand, Company, and health department regulations
Coaches team members to follow guidelines for food preparation and production management
Cascades relevant information to team members and assists with new product training

What we offer

Unlimited tip pooling
Medical, Dental, Vision, Term Life and AD&D plans
Flexible spending and health savings accounts
Short-Term Disability
Vacation paid time off
Company holidays paid at time and a half
Matching 401(k)
Tuition Reimbursement
Stock Purchase Plan
Employee Discount Program

Fulltime

New

Plant Operator - Crushing and Screen

Are you an experienced and ticketed Machine Operator looking for stable, high-ho...

Location

Australia , Petrie

Salary:

42.00 - 52.00 AUD / Hour

Randstad

Expiration Date

July 09, 2026

Requirements

Proven Experience working in a quarry, concrete recycling, or heavy industrial yard
Current tickets for Front-End Loader (LL) and Excavator (LE)
Truck License: Heavy Rigid (HR) or higher is highly regarded
Reliability with strong work ethic and punctuality
Own reliable vehicle and current driver's license

Job Responsibility

Safe and efficient operation of heavy machinery in a fast-paced recycling and quarry environment
Operating Front-End Loaders
Operating Excavators utilized as material handlers
Operating Moxy (Articulated Dump Trucks) and other yard machinery as required
Assisting with daily machinery pre-starts, basic maintenance, and ensuring the yard runs smoothly
Adhering strictly to site health and safety protocols

What we offer

Top Rates: $42.00 to $52.00 per hour + overtime penalties
Big Hours: Consistent 40 to 55-hour work weeks
Career Progression: Pathway from casual to permanent full-time employment within 3-6 months
Local Work: Convenient Brisbane Northside location (Petrie)
Immediate Start

Fulltime

Graduate Student Instructors

Location

United States , Ann Arbor

Salary:

Not provided

University of Michigan

Expiration Date

Until further notice

Requirements

Enrolled in good standing as a graduate student at the University of Michigan
Available to teach the scheduled section times
Have previously taken at least 1 philosophy course (or equivalent course) in this general area as an undergraduate or graduate student, and have demonstrated expertise and interest in subject area
Experience with Canvas
If the language of instruction at a student's undergraduate institution was not English, they must be evaluated by the English Language Institute (ELI) for English proficiency and either pass the GSI-OET or have this test waived by the ELI before they can be eligible for a GSI appointment in LS&A.

Job Responsibility

Attend all lectures and exams for your preferred course
Run discussion sections as scheduled
Hold at least 2 office hours each week
Grade assignments, per lead faculty instruction
Meet weekly with the lead instructor, and respond promptly to emails
Additional items listed in fraction calculation form

Parttime

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Manager, C&Q Document Preparation (Drug Product)

Job Description

Job Responsibility

Requirements

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