Quality Control Investigator- Chemistry

2 weeks ago

Mississauga, Canada SGS Full time
Job Description

  • Leads OOS’s, Deviations, and CAPA’s technically and administratively. 
  • Conducts OOS investigations on a daily basis where SOP and regulatory guidelines are followed. Writes the OOS with feedback from the SME’s/Managers/QA and reviews all associated raw data and records; Leads the determination of sequence of events and leads root cause analysis. Develops hypothesis testing plans in collaboration with Quality Assurance, subject matter experts, and the client. Provides systematic and detailed OOS reports. Decides together with operations and quality assurance on corrective/preventative action plans for OOS due to SGS.
  • Completes investigations on-time as per investigation SOP.
  • Participates or champions CAPA /Complaint process. Investigates CAPAs on behalf of QC. Participates in CAPA investigations if requested by CAPA owner or QA. Reviews CAPAs according to CAPA SOP.
  • Performs validation, or other failure investigations.
  • Follows up on corrective action
  • Perform corrective action for internal audits and external audits
  • May support preparation of responses to external audit reports by providing responses on behalf of operations.
  • Ensure that client requests and complaints are dealt with effectively.
  • Initiates deviations, leads and investigates deviations, justifies and performs root cause analysis and corrective action according to internal SOP and regulations.
  • Contributes to on time CAPA process according to SGS SOP. May write stability protocols as per client requests and communicates effectively with clients if required.
  • May write/Review QC methods.
  • May write/review validation protocol or reports of methods or equipment.
  • May perform review of calibration records or testing records.
  • May perform impact assessments.
  • Informs applicable personnel in time if work cannot be satisfactorily completed on scheduled time, so other resources can be utilized to meet the deadline.
  • Attend training sessions and ensure that training binder is current.
  • Keep the working areas clean and organized according to laboratory procedures.
  • Training departmental staff on documentation, regulatory issues and corrective action.
  • Perform other assigned laboratory / quality control duties as requested by supervisor.
  • Provides leadership in compliance.
  • Prepares weekly reports of progress on assignments.

Qualifications

  • Minimum education B.Sc. (M.Sc. or higher preferred) In Biology, biochemistry or related fields.
  • Experience: over 5 years pharmaceutical testing experience with exposure to root cause investigations and quality management systems.
  • Skilled in pharmaceutical testing individual who has experience / capability to perform thorough investigations into root cause analysis
  • Knowledge of OOS Investigation regulatory process
  • Knowledge and experience of using root cause analysis tools
  • Thorough knowledge of scientific principles pertaining to records under investigation.
  • Works well under pressure and tight deadlines.
  • Ability to work fast and make timely decisions where required (e.g. hypothesis testing, repeat test approvals etc.)
  • Proven time management skills. Managing multiple assignments.
  • Highly organized
  • Deliver results in a timely manner
  • Proven track of working well with others.
  • Excellent written and verbal communications
  • Candidates must be proficient in using various type of computer software (Word, Excel, PowerPoint, Outlook etc.) and be able to demonstrate good keyboarding skills.
  • As per Orientation and Training SOP all employees must maintain appropriate attitude, constant vigilance and attention to detail in the execution of all their duties.
  • All training is kept up to date and relevant in advance of conducting any work where training is required
  • Incumbents are responsible for their own training records according to training SOP.


Additional Information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression and Indigenous status, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities, or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.

Accommodations are available on request for qualified candidates during each stage of the recruitment process.

Please note that candidates applying for Canadian job openings should be authorized to work in Canada.

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