incident investigation writer

  • Location: Mont Saint Guibert
  • Type: Perm
  • Job #16628

ORGANISATION

Our partner is a global pharmaceutical and services company with a unique combination of businesses focused on providing access to medicines to improve the quality of people's lives around the world. We are the global leading experts, trusted by both pharmaceutical and biotech companies and healthcare professionals, in providing access to medicines throughout the lifecycle of a medicine; clinical trials, unlicensed and commercial supply.

We are currently 1000+ people, headquartered in the UK, with global offices in the US, Asia Pacific, South Africa, and across Europe. Our mission is to deliver the right medicine to the right patient at the right time and to help achieve this, we’re always on the lookout for motivated, ambitious and committed individuals to join our highly successful team.

ROLE

This position is responsible for enabling CCSM to achieve best-in-class quality by taking the lead in Incident/Investigation and CAPA preparation while meeting scheduled timelines. This position partners with all functional area leaders and is result-focused by improving our Investigation/CAPA process.

  • Support both Operations and Quality by writing and ensuring effective implementation of CCSMs Incident Reports, Investigations, Corrective and Preventative Actions documents
  • Interview Subject Matter Experts (SMEs) and involved employee(s) investigating reported problems and assess the quality impact
  • Schedule investigational meeting(s) with the required team members(s)
  • Use problem solving techniques to identify root cause analysis, and develop strategic solutions based on employee interviews of each incident
  • Assist Operations in standard operating procedure development as needed
  • Document review and report generation as required
  • Document maintenance, storage and coordination, as requested
  • Communicate operational concerns and opportunities for improvement to department leaders
  • Discuss incidents in weekly Operations meetings
  • Know, understand and comply with CCSM’s standard operating procedures and policies
  • Lead by example in setting a positive, supportive and team driven culture in working with team members to effectively resolve issues in a timely manner
  • Perform other related job duties or responsibilities as assigned

REQUIREMENTS

  • 1-4 years of work experience in document preparation
  • Bachelor's Degree with 1 year of work experience or equivalent experience in documentation preparation
  • Working knowledge of GMPs, CFR and ICH guidelines preferred
  • Excellent written communication skills and active listening ability
  • Excellent time management skills for working within a fast paced, ever-changing environment
  • Must be a self-motivated learner to critically evaluate situations, adapt quickly in making timely and independent decisions
  • Excellent communication and leadership skills
  • Strong analytical and problem-solving skills
  • Ability to work with cross functional teams and build consensus
  • Maintain a high regard for confidentiality while dealing with all clients, proprietary and pharmaceutical related information
  • All Microsoft Office Products: Word, Excel, Outlook, PowerPoint
  • Other company proprietary software
  • Fluent in English and in French

If you are interested, you can send your cv : [email protected]

PM Solutions

  • Location: Mont-Saint-Guibert
  • Type: Perm
  • Job #14485
 

Project Manager Solution

Walloon Brabant – CDI

 

Our client is actively looking for a Project Manager Solution to strengthen its activities.

Our partner is active in the pharmaceutical sector and is looking for a person with a solid experience as Project Manager in the pharmaceutical sector and who has worked in clinical trial environment.

 

What are your responsibilities?

  • Coordinates with the Business Development Team regarding client contract creation specifications
  • Creates and maintains a project timeline based on client needs
  • Acts as a liaison between clients and the company.
  • Organize and lead client meetings, as deem appropriate based on study and client needs.
  • Manages the setup and implementation of clinical studies including, but not limited to, packaging and labeling, dispensing, distribution of clinical trial material and ancillary supplies to ensure accurate and timely receipt to client of study materials
  • Provides packaging solutions to clients based on their need and estimated start date
  • Work alongside Project Manager, Operations to ensure continue movement of assigned tasks.
  • Work alongside assigned Project Manager in other regions as project needs are identified.
  • Initial procurement packaging components and ancillary supplies required to complete project as applicable to specific project needs.
  • Provides label text requirements for clinical trials, with assistance from a third party who can provide translation and regulatory requirements
  • Utilizes project management tools to ensure time management in adequate planning, evaluation, and submission of risk assessment timelines on projects
  • Ensures that accurate billing of project hours are documented and billed correctly.
  • Partners with other team members in Operations to ensure processes and procedures are maintained.
  • Works with applicable department manager(s) to address, research, and resolve issues and concerns raised by clients
  • Delegates, provides instruction, and assists in training, as identified by Director of Project Management of other Project Management Team members.
  • Partners with Quality Assurance to develop or revise applicable documents (i.e. SOPs, Work Instructions, etc)
  • Partners with Quality Assurance and team members to ensure compliance of SOPs and correct deviations in a timely manner
  • Communicates operational, personal concerns, and opportunities for improvement to department leaders

 

Who are you?

  • Ability to lead, coach, and mentor employees to provide work direction in resolving issues as they arise 
  • Must possess a detailed and proactive approach to management in problem solving 
  • Exceptional interpersonal communication and listening skills 
  • Superior time management skills for working within a fast-paced environment 
  • Able to critically evaluate situations and adapt quickly in making timely and independent decisions 
  • Must demonstrate a high level of initiative and the ability to work well independently and as a team member 
  • Confidentiality of all clients’ proprietary and pharmaceutical related information is essential 
  • Strong awareness of ownership of assigned projects and responsibilities 
  • Cultural awareness while working across regions with internal or external team members 
  • Fluent in French and English

What can you expect?

A permanent contract is offered for this function with a salary package matching your skills & experience. The opportunity to develop your skills or to evolve within this company is also open.

You’re interested in this job? We kindly invite you to send an e-mail to [email protected]

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QA Validation Specialist

  • Location: Mont-Saint-Guibert
  • Type: Perm
  • Job #13915

QA Validation Specialist

Brabant Wallon – CDI

#validation #QA #masterplanning #qualification #GMP #GDP #GCP

Are you interested in the pharmaceutical industry and putting your knowledge of validation to good use?

Our client is actively looking for a QA Validation Specialist to strengthen its activities. Our partner is active in the pharmaceutical sector.

What are your responsibilities?

As QA Validation Specialist, you are in charge to

  • Put in place an active SVMP and keep it live and up to date
  • Ensure we have a validation system, sops and templates to enable us to perform
  • Meet the ever increasing validation requirements of audits and inspectors
  • Use risk-based approaches to make validation activities efficient, cost-effective and defendable
  • Validation Master Planning
  • Retrospective review of validation activities in order to prioritise and define future work
  • Writing a site validation master plan
  • Be able to lead a validation/qualification
  • Take the lead for validation activities from a Quality Perspective
  • Data Integrity risk assessment and principles

Who are you?

You are graduated as a Pharmacist’s degree or a Master Science. You have 5 years of experience in QA. You have experience in wide range of validation activities-facility qualification, equipment qualification, process validation, cleaning validation/verification. Knowledge of GMP, GDP and GCP is required. You fluently speak French and English.

What can you expect?

A permanent contract is offered for this function with a salary package matching your skills & experience. The opportunity to develop your skills or to evolve within this company is also open.

You’re interested in this job? You can send you cv at [email protected]