Pharma Quality Specialist Consultant Job at PA Consulting (Melbourn)

Pharma Quality Specialist Consultant

Hybrid working - our approach is to be in the office or on client site a minimum...

Location

United Kingdom , London

Salary:

Not provided

PA Consulting

Expiration Date

Until further notice

Requirements

Management Consultancy experience highly desirable
A scientific or technical background (life sciences, pharmaceutical sciences, quality or a related discipline)
Typically 8+ years experience within pharmaceuticals, biotechnology or life sciences, with a strong track record in GxP QMS transformation and implementation
Extensive experience drafting and managing quality documentation, including SOPs, standards, policies, forms and templates
Strong knowledge of global GxP regulatory frameworks, including FDA, EU GMP/EudraLex, MHRA, EMA and ICH guidance
Hands-on experience with supplier qualification, audits, CAPA and compliance management
Experience of RIM and PLM system implementation in regulated environments (highly desirable)
Knowledge of computer system validation and data integrity principles
Excellent problem-solving, communication and stakeholder management skills
QP status is highly desirable but not essential

Job Responsibility

QMS design and process transformation
Leading the design and implementation of GxP-compliant QMS across R&D, manufacturing, clinical and distribution environments
Conducting process mapping and gap assessments, and supporting the rollout of new or enhanced systems aligned to global regulatory standards (including GMP, GDP, GCP, GLP, FDA 21 CFR 210/211, EU GMP/EudraLex, ICH Q7/Q10)
Authoring, reviewing and maintaining quality policies, standards, SOPs, forms and controlled documentation, enabling sustainable compliance and operational excellence
Supporting effective change management, embedding best practices through close collaboration with quality, technical and business teams
Computer system validation and data integrity
Leading and advising on computer system validation (CSV) activities within GxP environments
Supporting the development of validation strategies, protocols, test scripts and data integrity controls in line with global regulatory expectations
Supplier quality and audit support
Applying hands-on experience in supplier qualification, evaluation and audit activities (internal and external)

What we offer

Health and lifestyle perks accompanying private healthcare
25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
Generous company pension scheme
Opportunity to get involved with community and charity-based initiatives
Annual performance-based bonus
PA share ownership
Tax efficient benefits (cycle to work, give as you earn)

Fulltime

Pharma Quality Specialist Consultant

Hybrid working - our approach is to be in the office or on client site a minimum...

Location

United Kingdom , London

Salary:

Not provided

PA Consulting

Expiration Date

Until further notice

Requirements

Management Consultancy experience highly desirable
A scientific or technical background (life sciences, pharmaceutical sciences, quality or a related discipline)
Typically 8+ years’ experience within pharmaceuticals, biotechnology or life sciences, with a strong track record in GxP QMS transformation and implementation
Extensive experience drafting and managing quality documentation, including SOPs, standards, policies, forms and templates
Strong knowledge of global GxP regulatory frameworks, including FDA, EU GMP/EudraLex, MHRA, EMA and ICH guidance
Hands‑on experience with supplier qualification, audits, CAPA and compliance management
Experience of RIM and PLM system implementation in regulated environments (highly desirable)
Knowledge of computer system validation and data integrity principles
Excellent problem‑solving, communication and stakeholder management skills

Job Responsibility

QMS design and process transformation
Computer system validation and data integrity
Supplier quality and audit support
Regulatory systems implementation
Regulatory and Qualified Person (QP) support
Client and stakeholder engagement

What we offer

Health and lifestyle perks accompanying private healthcare
25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
Generous company pension scheme
Opportunity to get involved with community and charity-based initiatives
Annual performance-based bonus
PA share ownership
Tax efficient benefits (cycle to work, give as you earn)

Fulltime

Pharma Quality Specialist Consultant

Our Life Sciences teams work with leading pharmaceutical, biotechnology and heal...

Location

United Kingdom , London

Salary:

Not provided

PA Consulting

Expiration Date

Until further notice

Requirements

Management Consultancy experience highly desirable
A scientific or technical background (life sciences, pharmaceutical sciences, quality or a related discipline)
Typically 8+ years’ experience within pharmaceuticals, biotechnology or life sciences, with a strong track record in GxP QMS transformation and implementation
Extensive experience drafting and managing quality documentation, including SOPs, standards, policies, forms and templates
Strong knowledge of global GxP regulatory frameworks, including FDA, EU GMP/EudraLex, MHRA, EMA and ICH guidance
Hands‑on experience with supplier qualification, audits, CAPA and compliance management
Experience of RIM and PLM system implementation in regulated environments (highly desirable)
Knowledge of computer system validation and data integrity principles
Excellent problem‑solving, communication and stakeholder management skills
QP status is highly desirable but not essential

Job Responsibility

QMS design and process transformation
Computer system validation and data integrity
Supplier quality and audit support
Regulatory systems implementation
Regulatory and Qualified Person (QP) support
Client and stakeholder engagement

What we offer

Health and lifestyle perks accompanying private healthcare
25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
Generous company pension scheme
Opportunity to get involved with community and charity-based initiatives
Annual performance-based bonus
PA share ownership
Tax efficient benefits (cycle to work, give as you earn)

Fulltime

Sr Director, MSAT

The Sr. Director, MSAT (Manufacturing Sciences, Analytics, and Technology) acts ...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences or equivalent experience required
Minimum of fifteen (15) years of relevant experience in cGMP manufacturing or equivalent
Proven experience leading innovation, managerial experience with extensive industry knowledge and an eye towards future technologies
Soft skills: Strategic thinking, adaptive thinking, and strong critical mindset. Strong business acumen and presentation skills. Excellent interpersonal, leadership, and communication skills. Impact & influence top leaders & external clients and regulators
Emphasis on aseptic processing and compliance required
Advanced-level verbal communication skills

Job Responsibility

Optimize the use of resources (human, fill finish equipment and support areas) across the organization in support of improving process robustness and forward-looking capabilities
Coordinates and supports cross functional teams with recommendations, advice, and action plans for complex investigations, change controls, gap analyses and risk assessments related to all manufacturing modalities
Oversees authoring and revision of compliance, change controls and other technical documentation to support critical MSAT changes
Assesses incoming client projects to ensure compatibility, compliance, and initial and ongoing profitability with AAI processes
Contributes advanced level support to internal and client audits when needed
Build and sustain common innovation roadmap between MSAT and Drug Product Manufacturing/Finishing to ensure continuum in innovation to accelerate client projects and sustainable process performance
Lead the client technical intake process team composed of engineers and specialists
Drive complex change management & anchor the changes in MSAT and with connected functions, Drug Product, Finishing, Quality Assurance and Quality Control
Responsible for exhibiting professional behavior with both internal and external business associates that reflect positively on the company and is consistent with the company’s policies and practices
Serves as key contact for clients during tech transfer and post manufacturing activities

Fulltime

QA Specialist

You will be a member of Pfizer’s dedicated and highly effective quality assuranc...

Location

Ireland , Dublin; Newbridge; Shanbally; Ringaskiddy; Little Island

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Relevant Third Level Qualification or Equivalent (Exceptions may be considered where relevant skills/experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel)
Minimum 2 years experience as detailed above in the job responsibilities section, within a QA/QC GMP environment in a Pharma/Biotech company
Excellent communication and interpersonal skills
An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment
Proactive approach and strong critical thinking skills

Job Responsibility

Support operations through real time batch review ensuring all batch manufacturing records (paper / electronic) and associated manufacturing deviations are reviewed in a timely manner and in accordance with release schedules
Support issue resolution, incident routing and deviations
Complete walkthrough audits to ensure the area is maintaining cGMP compliance standards
Attend IMEx meetings and ensure timely escalation of issues to the QA Manager
Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives
Review and approval of validation documents Process, cleaning & method validation
Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filings
Ensure that production instructional documentation (SOPs and batch records) are up to date, compliant, and supports RFT (right first time) production, and that all in -process control limits and specifications have been met
Review all operational SOP’s, forms, protocols and reports, and any related documentation as applicable
Ensure all batch deviations are reported in accordance with Pfizer corporate standards

Fulltime

Accountant

We are seeking a detail-oriented Accountant to support daily accounting operatio...

Location

United States , Miami

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Accounting, Finance, or related field
2+ years of accounting experience
Knowledge of general accounting principles and financial reporting
Experience with general ledger, reconciliations, and close processes
Proficiency in Microsoft Excel and accounting software or ERP systems
Strong attention to detail, organization, and problem-solving skills
Ability to work independently and collaboratively in a team environment
Strong written and verbal communication skills

Job Responsibility

Prepare and record journal entries, accruals, and adjustments
Maintain and reconcile general ledger accounts
Perform monthly bank and account reconciliations
Assist with month-end, quarter-end, and year-end close
Prepare financial statements, reports, and supporting schedules
Analyze account activity and investigate discrepancies
Support accounts payable, accounts receivable, and payroll processes as needed
Help ensure compliance with company policies, internal controls, and accounting standards
Assist with audits by preparing documentation and responding to requests
Contribute to budgeting, forecasting, and variance analysis

What we offer

medical insurance
vision insurance
dental insurance
life insurance
disability insurance
401(k) plan

Fulltime

Critical Environment Technician Manager

In alignment with our Microsoft values, we are committed to cultivating an inclu...

Location

United States , Mount Pleasant

Salary:

75400.00 - 167900.00 USD / Year

Microsoft Corporation

Expiration Date

Until further notice

Requirements

High School Diploma, GED, or equivalent AND 3+ years mission critical services work/applied learning experience (e.g., high availability assembly/manufacturing/critical infrastructure environments such as data centers, oil and gas refineries, hospitals, pharmaceutical, manufacturing, or related fields) OR equivalent experience
Ability to work shifts, including shift assignments during non-standard business hours that may include evening, nighttime, weekends, and/or holidays
Ability to meet Microsoft, customer and/or government security screening requirements are required for this role
High School Diploma, GED, or equivalent AND 6+ years mission critical services experience OR Associate's Degree or technical trade certification (e.g., military, trade school), or higher-equivalent education AND 5+ years mission-critical services experience OR equivalent experience
1+ year(s) people management experience
1+ year(s) experience in a specialized area (e.g., mechanical field, electrical field, controls field) or related field

Job Responsibility

People Management: Managers deliver success through empowerment and accountability by modeling, coaching, and caring. Model - Live our culture
Embody our values
Practice our leadership principles. Coach - Define team objectives and outcomes
Enable success across boundaries
Help the team adapt and learn. Care - Attract and retain great people
Know each individual’s capabilities and aspirations
Invest in the growth of others
Equipment and Systems Operations: Serve as an operations specialist one or more major area of operations (e.g., electrical, mechanical, controls, generators, and work on advanced tasks independently. Oversee and coach team with the inspection of critical environment-related facility equipment (e.g., controls, heating, ventilation, and air conditioning [HVAC], mechanical systems), building, and grounds regularly for unsafe or abnormal conditions to develop and analyze trends. Monitor performance of maintenance and operations utilizing telemetry, control systems, and other platforms and is able to identify all alarms. Utilize internal computerized maintenance management system (CMMS) to track all equipment assets and to complete work order requests for maintenance work and generate reporting to identify outstanding and ongoing work orders. Safely and quickly respond to and lead an onsite incident response team for all abnormal conditions that impact operations and coordinate with other critical facilities professionals to perform corrective repairs. Enhances, develops new, or follows preexisting emergency operating procedures (EOPs), methods of procedure (MOPs), and standard operating procedures (SOPs) in relation to incidents. Gathers necessary information and creates incident timelines/data, root-cause analyses, and/or action items following an abnormal condition
Equipment and Systems Maintenance: Guide, oversee, and perform various types of maintenance (e.g., planned, predictive, corrective) and repairs following methods of procedure (MOPs), and standard operating procedures (SOPs) for one or more disciplines and one or more types of equipment (e.g., electrical, mechanical, cooling systems) and escalate when appropriate. Serve as a subject matter expert for one type of equipment and oversee everyday tasks and troubleshooting within their area of expertise. Have a hands-on understanding of how equipment works within disciplines they have been trained and how to troubleshoot equipment, systems, subsystems, and components independently within their trained discipline(s). Provide and/or assign team to provide necessary escort to third-party contractors, sub contractors, vendors, and service providers on site for all severity leveled procedures. Coordinate and schedule supplier/vendor on-site activities and recognizes circumstances when to stop supplier work to address potential and/or identified concerns. Take part in getting third-party work underway (e.g., making sure systems are properly energized/deenergized), ensuring the work is started and completed in a safe manner in accordance with standard practices, procedures, federal/local legislation, and municipal codes. Advises junior colleagues on inspection and supervision issues. Provides consultation to lower-level colleagues in troubleshooting systems and problems
Critical Environment Culture: Understands, follows, ensures, and coaches team on safety and security requirements (e.g., job hazard assessments [JHAs], toolbox talks), and business processes and procedures to properly perform work in a safe, quality, and reliable manner in accordance with applicable federal, state, local, and Microsoft requirements. Proactively ensures safety and security requirements are followed and met for the work of themselves and others. Maintain safe working conditions and escalate immediately when unsafe working conditions are observed. Assesses and identifies appropriate resources and equipment necessary to fully support environmental health and safety (EH&S) objectives. Participates in required meetings, trainings, and necessary handoffs

What we offer

Benefits and other compensation (details at https://careers.microsoft.com/us/en/us-corporate-pay)

Fulltime

Psychologist/Psychological Assessment and Evaluation

Join a clinician-centered multidisciplinary team of counselors, social workers, ...

Location

United States , Georgetown

Salary:

Not provided

Ellie Mental Health

Expiration Date

Until further notice

Requirements

Clinical licensure is required (PhD or PsyD)
Experience with completing diagnostic evaluations, scoring and interpreting results, writing reports that clients can understand, and providing feedback to clients
Comfort and familiarity working with a diverse client base from an affirming perspective
Candidates must be able to work in Maryland with a Maryland license, or be license-eligible
Opportunity to provide supervision to psychology associates and trainees for qualified candidates with a demonstrated history of success with Ellie

Job Responsibility

Completing diagnostic evaluations
Scoring and interpreting results
Writing reports that clients can understand
Providing feedback to clients
Providing supervision to psychology associates and trainees for qualified candidates

What we offer

Competitive salary
Flexible schedule
Opportunity for advancement
Health insurance
PTO
Weekly case consultation groups
Free CEUs
Monthly team activities focused on clinician well-being
We will cover all testing costs and expenses as well as administrative tasks like marketing, scheduling, and billing
Cash pay service: clients pay upfront, and you’ll earn 50% of what we collect

Fulltime

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Pharma Quality Specialist Consultant

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