Immediate Opening!

Shields Pharma Inc. is looking for qualified and experienced employees to join the successful team. We currently have the following full time positions available for Markham:

Quality Assurance Specialists

Reports To: Manager of Quality

Outstanding opportunity for Quality Assurance professionals to join our company based in Markham as Senior Quality Assurance Specialists. As the Quality Assurance Specialist you will be responsible for the maintenance of the QA function and ensuring compliance according to GMP (Good Manufacturing Practice), and will perform activities to assure compliance with applicable regulatory requirements by conducting audits, supporting training programs, data and documentation reviews and analysis.

Responsibilities:

• Manage the GMP Documentation, Change Control, CAPS, OOT, OOS, Training Record systems.
• Review and approve CoA and other quality documentation
• Review validation activities
• Assess regulations
• Develop quality policy
• Perform timely data review with a high focus on data quality to ensure accuracy and completeness of analytical testing documentation.
• Oversee Quality Control documentation to enforce good documentation practice to improve accuracy, GMP compliance and neatness of analytical documentation
• Verify calculations and documented information such as reagent expiry, instrument calibration, logbook entries, control charts etc are present and complete and accurate.
• Review internal logbooks for incoming samples, standards, reagents, equipment etc.
• Issue and reconcile Quality Control laboratory workbooks and other GMP documentation.
• Audit and inspect laboratory equipment daily use logbooks
• Ensure analysis performed are as per client’s specification
• Track tests in progress and issue periodic status reports
• Support training initiatives by implementing training program, including monitoring effectiveness of program and ensure training records are compliant
• Implement Quality Policies and Procedures for on-site test activities
• Develop, implement and update QA Manual, QA Supplement Manual and standard operating procedures
• Prepare, review and approve Standard Operating Procedures (SOPs)
• Coordinate documentation activities to ensure compliance with GLP and GMP
• Archive and retrieve quality control data
• Audit and inspect laboratory operation and activities
• Audit and review data for accuracy, completeness and regulatory compliance
• Detailed audits of draft reports for compliance with SOP’s and GLP regulations
• Participate in client audits and inspections
• Participate in regulatory audits and inspections
• Oversee the laboratory investigation
• Perform Annual Internal Audit, and work with Analytical Lab personal to ensure follows up and corrective actions are completed.
• Periodic review of training records, SOPs, Change Control implementation, Deviation and OOS investigation
• Data-review and data-verification activities
• Maintaining and issuing controlled numbers in support of site-wide document control
• Tracking document requests and ensure completion of outstanding items
• Conduct QA investigation with regard to Out-of-Specifications, Exceptions and Corrective Action. Monitor effectiveness of corrective and preventative actions.
• Assist in the review and approval of GMP documents such as SOPs, and associated forms, and initiate revisions.
• Evaluate laboratory results and keep trending of Shields Pharma Inc. Stability studies and write assessment reports of these programs annually.
• Any other tasks assigned by the Shields Pharma Inc. senior management

Education and Experience:

• University Degree in Science – preferably in Chemistry coupled with experience in the review of raw material, finished product, stability and analytical method validation documentation.
• Have experience in a Quality Assurance leadership role with minimum of 3 yrs quality experience in a regulated pharmaceutical environment, within QA, QC, and/or Regulatory Affairs disciplines.
• Have expert experience of GMP Thorough understanding of pharmaceutical QA Systems, US, EU, and Canadian GMP regulations
• Knowledge of GMP, GLP, Compendia, analytical techniques
• You should have excellent verbal and written communication skills, interpersonal skills and you should be extremely results driven and organized
• You must demonstrate good written and oral communication skills in English

General Skills:

• The requirements listed below are representative of the knowledge, skill, and/or ability required.
• Must be willing to work in a team-based environment
• Must have solid math skills
• Must be able to work with limited direct supervision
• Must have good problem solving/organizational skills
• Must have excellent computer skills
• Must have strong writing and communication skills in English
• Must have the ability to analyze data
• Must be attentive to detail
• Must have excellent organizational skills to meet frequent changes in immediate priorities, problem solving skills, and understanding of various computer software programs required

The above positions are only applicable to permanent residence and/or Canadian citizens with a minimum degree in science.

To apply, please reference “QA Specialists” in subject line and submit resume with cover letter to mmassoudinia@shieldspharma.com

We thank all applicants for their interest, however, only those selected for an interview will be contacted. No phone calls please.

Immediate Opening!

Shields Pharma Inc. is looking for qualified and experienced employees to join the successful team. We currently have the following full time positions available for Markham, Ontario:

Quality Assurance Manager

Overall Responsibilities:

QA Manager will perform activities to assure compliance with applicable regulatory requirements by conducting audits, supporting training programs, performing data and documentation review/approval, and ensuring adherence to applicable regulatory guidelines in all aspects of operation at Shields Pharma Inc.

Duties of QA Manager shall include, but are not limited to, the following:

• Provides management and guidance to Quality Assurance department staff to ensure the department is in compliance with current Good Manufacturing Practices (cGMP) and company policies, safety and labor regulations.
• Direct, delegate assignments and review work assigned
• Prepare and/or review/approve deviations, investigations, protocols, lab data, SOPs and any other reports or documents as needed
• Provide support, direction and coaching to subordinate employees in the areas of the QA department
• Assist with preparation and participate in HPFBI/FDA or other compliance audits
• Assist with preparation and participate in client audits
• Preparation of written response to client/regulatory observations
• Give critical review and guidance for protocols and product dispositions for deviations, investigations, etc
• Give guidance and support on cGMP compliance
• Develop and provide sufficient SOP and GMP training programs
• Ensure Metrology, Computer Validation, Microbiology, and Chemistry testing programs are performed in a complete, compliant and accurate manner, and adhere to applicable regulatory guidelines
• Prioritize departmental activities in alignment with the regulations, and client/corporate goals. 
• Develop and monitor effectiveness of CAPA, Change Controls, TAR/OOS Reports.
• Streamline systems as needed to conform to cGMP and company objectives
• Help develop annual budget expectations for QA department that includes but not limited to QA head count requirements to meet workload projections
• Develop metric and benchmarking reports for presentation to top management
• Present information to top management, public groups, and/or boards of directors
• Any ad-hoc tasks assigned by the Shields Pharma’s Senior Management

Qualifications and required skills

• Completed Bachelor of Science degree with a focus on Chemistry
• GMP and QA related experience or equivalent, a majority of which are in the area of quality assurance and compliance experience.
• Demonstrated experience in a Quality Supervisory capacity
• Experience in managing relationships with vendors and clients
• In depth knowledge of cGMPs and related Health Canada Acts, FDA, and European regulations
• In depth knowledge of cGDP and related documentation practices
• Intermediate level knowledge of MS Word, Excel and Outlook
• Demonstrated good communication and writing skills
• Strong supervisory skills including delegation, time management, work allocation and leadership

The above positions are only applicable to Canadian citizens with a minimum degree in science and five years of direct experience.

To apply, please reference “QA Manager” in subject line and submit resume with cover letter to mmassoudinia@shieldspharma.com

We thank all applicants for their interest, however, only those selected for an interview will be contacted. No phone calls please.

Shields Pharma Inc. is looking for qualified and experienced employees to join the successful team. We currently have the following full time positions available for Markham, Ontario:

Document Reviewer

Responsibilities:

• Perform timely data review (including drug substances, excipients, in-process materials, drug products, stability, analytical method validation documentation, microbiological testing etc.) to ensure accuracy, completeness and compliance with GLP, GMP, all applicable SOPs and regulatory requirements.
• Perform internal audits ensuring the lab operations are carried out according to approved procedures and in accordance with GMP/cGMP requirements.
• Review laboratory notebooks for incoming samples, standards, reagents, equipment etc.
• Issue and reconcile controlled laboratory notebooks and other GMP documentation.
• Archive and retrieve laboratory data and reports.
• Periodic review of training records, SOPs, change control implementation, deviation and OOS investigations.
• Prepare for and participate in client audits and regulatory inspections as required.
• Oversee data review, documentation, C of A preparation activities as required.
• Perform other tasks as required.

Education and Experience:

• University degree in Science – preferably in Chemistry with experience in the review of data from chemistry and microbiology laboratories.
• A minimum of 3 years Quality Assurance Document Reviewing experience in a regulated environment
• Strong understanding of quality systems, Canadian, US, EU GMP requirements.
• Knowledge of Compendia, analytical techniques and method validation.
• Excellent verbal and written communication skills; and interpersonal skills.
• Extremely results driven and organized.

The above positions are only applicable to permanent residence and/or Canadian citizens with a minimum degree in science.

To apply, please reference “Document Reviewer” in subject line and submit resume and cover letter with salary expectation to mmassoudinia@shieldspharma.com.

We thank all applicants for their interest, however, only those selected for an interview will be contacted. No phone calls please.

Immediate Opening!

Shields Pharma Inc. is looking for qualified and experienced employees to join the successful team. We currently have the following full time positions available for Markham, Ontario:

Senior Laboratory Analysts with HPLC, GC GC-MS Experiences

Reports To: Laboratory Supervisor
Location: Markham, Ontario

The successful candidate will be working in a very fast paced environment by performing full analytical testing of assigned materials or products within standard times and under minimal guidance/supervision. This position relies heavily on comprehensive wet chemistry techniques, Dissolution, HPLC, GC, AA testing on raw materials, in-process and final products per established SOP’s and pharmacopoeial product specifications.

Duties shall include, but are not limited to, the following:

• Document and report results in accordance with GMP and GLP
• Conduct laboratory investigation as required
• Provide technical support to other analysts
• Perform trouble-shooting on complex issues with respect to laboratory analysis and laboratory instrumentation
• Perform all work in accordance with all established regulatory, compliance and safety requirements
• Train junior analysts as required
• Maintain professional relationship with Internal/External Customers
• Any ad-hoc tasks assigned by the Shields Pharma management
  
  

Qualification:

• Permanent residency and/or Canadian citizenship
• B.Sc. degree in Chemistry or related discipline is a must
• Minimum of 5 years Quality Control experience in the Pharmaceutical/Nutraceutical discipline, ideally in contract testing
• Knowledge of GMP, GLP, Compendia, analytical techniques and method validation
• Superior organizational and interpersonal skills
• Ability to manage multiple projects concurrently and effectively
• With GC experience
• Sound theoretical and technical knowledge of chromatographic sciences and spectroscopic technologies such as UV, IR, GC, HPLC, AA, TOC
• Sound understanding of cGMP, ICH and FDA requirements
• Excellent written and oral communication skills is a must
• Computer proficiency with MS Office programs
• Ability to meet deadlines and prioritize tasks with strong attention to detail

The above positions are only applicable to permanent residence and/or Canadian citizens with a minimum degree in science and five years of direct experience.

To apply, please reference “Senior Laboratory Analyst” in subject line and submit resume with cover letter to mmassoudinia@shieldspharma.com

We thank all applicants for their interest, however, only those selected for an interview will be contacted. No phone calls please.

Shields Pharma Inc.  is looking for qualified and experienced employees to join the successful team. We currently have the following full time positions available for Markham, Ontario:

Junior Metrology

Overall Responsibilities:

The candidate will perform qualification and maintenance activities of lab instruments and equipment.

Specific Tasks:

• Participate in new instrument requirement determination activities.
• Develop instrument qualification documents including but not limited to:
  • IQ, OQ and PQ Protocols
  • IQ, OQ and PQ Summary Reports
• Execute qualification protocols.
• Write and review related technical documents.
• Maintain calibration and preventative maintenance schedule.
• Develop and formalize calibration procedures ensuring all laboratory instruments have calibration SOPs.
• Perform calibration testing in accordance with these procedures.
• Perform preventative maintenance on analytical instruments.
• Monitor maintenance status of individual instruments and coordinate with external service technicians as required.
• Maintain calibration data in an organized format.
• Perform all work in compliance with GXP, company SOPs and regulatory and safety standards.
• Perform other related duties as assigned.

Expectations:

We are looking for an independent and self-sufficient person willing to learn. Critical thinking a must. Specialized and specific training will be provided. Ours is a fast-paced environment with multiple responsibilities offering unparalleled exposure to analytical instrumentation in use in pharmaceutical environments.     

The above position is only applicable to permanent residence and/or Canadian citizens with a minimum degree in science and minimum of 2 years of pharmaceutical lab experience with emphasis on instrumental methods.

To apply, please reference “Metrology” in subject line and submit resume and cover letter with salary expectation to mmassoudinia@shieldspharma.com

We thank all applicants for their interest, however, only those selected for an interview will be contacted. No phone calls please.