QA Coordinator - Mississauga, Canada - PCI Pharma Services

PCI Pharma Services
PCI Pharma Services
Verified Company
Mississauga, Canada

2 weeks ago

Sophia Lee

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Sophia Lee

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Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.


JOB SUMMARY


Responsible to provide administrative, documentation and training support to the Quality Team, ensuring that documentation is in compliance with all applicable regulations, Good Manufacturing Practices (GMPs), Standard Operating Procedures (SOPs).

SKILLS, KNOWLEDGE/EXPERIENCE REQUIRED TO PERFORM THE JOB

  • Postsecondary education in business administration or related field
  • Minimum 1 to 3 years' experience in an administrative support role, preferably in the pharmaceutical or packaged goods industry
  • Technical writing skills
  • Excellent communication skills (oral and written)
  • Computer knowledge to use software programs such as Microsoft Office, proprietary software programs, internet navigation, ERP etc.
  • Proficiency with the English language
  • Strong aptitude for figures
  • Excellent time, project management, attention to detail and negotiation skills
  • Excellent interpersonal and organizational skills
  • Excellent team player to with the ability to effectively participate in team meetings
  • Must be able to work with limited supervision
  • Demonstrated commitment to our fundamental principles of integrity, respect and excellence

MENTAL EFFORT REQUIRED TO PERFORM THE JOB
Mental attentiveness and alertness is required constantly on the job, accuracy and attention to detail being critical parameters. Must be able to deal with frequent changes to priorities.


PHYSICAL EFFORT REQUIRED TO PERFORM THE JOB
Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation, including keyboard equipment. Lifts light items for limited duration.


RESPONSIBILITIES ASSOCIATED WITH PEERFORMING THE JOB

  • Provide administrative support to the department as required
  • Manage precise and accurate filing systems
  • Administer the documentation for absences, vacations, sick time, scheduling as required
  • Document management for the department (ie. SOPs, Certificates of Analysis (CofA's), Material Safety Data Sheets (MSDS), protocol files, packaging documentation) and arrange for offsite storage if required
  • Administrative support of deviation reporting/tracking/trending processes
  • Assist in updating of SOPs such as managing revisions and reformatting
  • Ad hoc support to Quality Director and QA Associates during audits (provision of documentation, retrieval of files etc.)
  • Administrative support to acquisition, collation, and reporting of KPI data
  • Support provided to audit follow up and other quality improvement (CI) activities
  • Update all departmental SOPs as needed, based on input from management tracking version control
  • Assist with the onboarding of new employees. Setup of accounts in QMS system and ERP system.
  • Coordinating SOP and other training sessions for the department
  • Organize and schedule annual GMP training
  • Manage signature log
  • Ensure all annual testing and CV/resume updates are on file
  • Work with Managers/Supervisors to update curriculums for their department
  • Manage all employees' training records, identifying when retraining is required
  • Back up support to the various functions of the QA Team as required
  • May be essential to perform alternating or rotating shift work as required
  • Other duties as required

SUPERVISION
Reports to the Quality Director.


WORKING CONDITIONS WHILE PERFORMING THE JOB
Located in a comfortable indoor area. Any unpleasant conditions would be infrequent and of short duration.

Join us and be part of building the bridge between life changing therapies and patients.

Let's talk future


Equal Employment Opportunity (EEO) Statement:

  • PCI Pharma Services is an Equal _
  • Opportunity/Affirmative_
  • Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
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