- Position : Quality Assurance Associate, Computerized Quality Systems (12 month contract)
- Department : Corporate Quality
- Requisition :18HRCN-086
- Job Type : Contract
- Posting Date : 11/19/2018
- Location : Brampton, Canada
The position will ensure that data systems (automated and non-automated) are compliant to current regulatory expectations related to CFR Part 11, GAMP 5 and Data integrity requirements. Provide support to sites for the oversight of Data Governance Plans to ensure that data integrity is maintained for all records, paper, hybrid and electronic, required under GMP throughout the data lifecycle.
Principal Duties and Responsibilities :
- Provide Quality oversight of critical data systems for all Taro locations and major business partners.
- Provide Quality oversight activities related to design, installation, qualification, maintenance of global automated systems such as LIMS, TrackWise, SAP, etc.
- Provide guidance and support to the site Data Governance Officers for the purpose of overseeing the Site Data Governance Plans.
- Perform oversight of the assessment of all systems (paper, hybrid or computerized) of the site level delivered by the site Data Governance Officers and Business Data Stewards. The oversight should ensure that assessment was performed using a risk based approach and commensurate with the risk of the system on data integrity throughout the data and product lifecycles.
- Perform internal audits of Site Systems to ensure alignment with the requirements of the Taro Site and Global SOP’s and Policies.
- Report on new compliance regulations from Regulatory authorities related to Data Integrity and Data Governance.
- Act as the official designate for the Director, Corporate Quality, IT and Computerized Quality Systems.
- Support the site Quality IT and computerized systems as needed. (*)
- (*): Due to the temporary nature of the position and the project loads, the associate might be requested to support the site QA IT and Automated systems functions on an Ad Hoc basis. During these tasks, the reporting structure might change to the site Quality head.
Knowledge, Skills and Abilities
• Experience in inspection from Regulatory agencies officials (Health Canada, USFDA, MOH, MHRA).
• Knowledge of cGMP, FDA, HPFBI and associated guidelines related to Data Integrity and Data Governance.
• Enthusiastic and self-motivated.
• Strong analytical and problem solving skills.
• Ability to effectively analyze problems, exercise sound judgement and make timely decisions.
• Ability to influence without authority.
• Strong ability to extract information by questioning, active listening and interviewing to elicit and formally define requirements.
• Demonstrated ability to work under pressure and manage conflicting priorities.
• Excellent organizational skills and multi-tasking ability.
• Excellent written and verbal communication.
• Problems associated with a wide variety of data integrity or data governance challenges.
• Problem solving associated with dealing with multiple departments simultaneously.
Background and Experience:
• Minimum of B.Sc. Chemistry or other associated field.
• At least 5 years at the supervisory/management experience (preferred).
• Experience in pharmaceutical computerized systems.
• Experience in data integrity and data governance (preferred).
If you are interested in this opportunity, please submit your resume to firstname.lastname@example.org referencing Quality Associate, IT and Computerized Quality Systems in the subject line. We thank all applicants, but only those selected for further consideration will be contacted. No phone calls please.
This position is open to applicants legally authorized to work in Canada.
Taro Pharmaceuticals embraces diversity in the workplace and is committed to achieving employment equity. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We ensure that our recruitment practices are supportive of this commitment and do not infringe on any characteristics protected by law.
In accordance with the Accessibility for Ontarians with Disabilities Act, 2005, and the Ontario Human Rights Code, Taro Pharmaceuticals will provide accommodation throughout the recruitment and selection process to applicants with disabilities. If selected to participate in the recruitment and selection process, please inform Human Resources of the nature of accommodation(s) that you may require in respect of any materials or processes used to ensure your equal participation.
NOTE: All employment is conditional upon the completing and obtaining of a satisfactory background check which may include educational, employment, references and criminal records (for which a pardon has not been granted) checks.
AGENCY NOTICE: Please note that Taro Pharmaceuticals does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with an agency / recruiter, Taro Pharmaceuticals will not consider any referrals or agree to payment of referral or recruitment fees. In the event a recruiter or an agency submits a resume or candidate without a previously signed agreement, Taro Pharmaceuticals explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.
To learn more about Taro Pharmaceuticals Inc., please visit: www.taro.ca.