- Position : Specialist, Quality Compliance (Investigations QA)
- Department : Quality Assurance (QA)
- Requisition :req8473
- Job Type : Full Time
- Posting Date : 11/27/2020
- Location : Brampton, Ontario
Taro is a multinational; science-based pharmaceutical company dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.
Our Brampton location is presently looking for a Specialist, Quality Compliance (Investigations QA) to join our QA department.
To provide assistance and support to the Director and Managers of Quality Assurance, regarding compliance activities within the department. This will entail coordination with other departments within the organization.
Principal Duties and Responsibilities :
- Perform multiple QA of QC duties, which include random verification and review of QC documentation (Analytical Record’s, Phase I OOS, etc.)
- Monitor and review documents regarding products, raw materials and test methods based on compendial updates
- Trend, analyze and follow up on OOS Investigations.
- Create and follow up on all Phase II OOS investigations
- Work closely with Lab personnel for protocol generation and review for Phase II lab testing (OOS Investigations)
- Provide support for initiation and investigation of deviations originating from the QC laboratory.
- Monitor and review documentation for residual solvents, melamine and other compendial or regulatory submission requirements
- Provide support for Compendial updates.
- Review QC specifications for compliance
- Perform internal/external audits when required.
- Provide support to QA & Regulatory Affairs Departments as required.
- Duties may require occasional contact with the Pharmacopoeial & Regulatory bodies.
- Complete all GMP Documentation correctly and in a timely manner
- Complete all training assignments and maintain personal training records
- Participate in and/or lead Non Conformance Investigations
- Complete Corrective and Preventive Actions (CAPA’s)
- Initiate, and follow through with actions required to close Change Controls
- Participate in Internal, Customer and Regulatory Audits.
- Other duties as assigned
Knowledge, Skills and Abilities
- University degree in Science – preferably Chemistry
- Knowledge of USP and Regulatory requirements for the pharmaceutical industry
- Knowledge of QC Laboratory Systems, procedures and equipment Systems
- Software skills (Microsoft Word, Excel, PowerPoint, document management systems)
- Minimum of 5 years laboratory experience in the Pharmaceutical industry.
- Organizational ability to maintain a complex and high volume of technical information up to date
- Familiarity with appropriate GMP compliance requirements of pharmaceutical industry
- Excellent interpersonal skills and communication skills (verbal and written)
- Superior level of computer and software skills
If you are interested in this opportunity, please submit your resume to email@example.com referencing Specialist, Quality Compliance (Investigations QA) 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.