Mid-level industry position
- Department : Quality Control
- 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 LIMS QC Coordinator on a contract basis to join our Quality Control Department.
The main responsibility for this position is to coordinate activities and enter master data within the LIMS system to meet Taro, Canadian and FDA GMP requirements.
Principal Duties and Responsibilities :
- Understanding Chemistry and Laboratory Practices in the Quality Control Department, the coordinator will look to maintain compliance with the regulatory agencies and best GMP/GLP practices.
- Assist in uploading activities for static data in LIMS, ensuring all appropriate cross referencing is in place in the different modules (instruments, reagents etc).
- Verify, update & review static data (specifications, methods, etc.) in LIMS.
- Assist in validating entered data by challenging at extremes and borderline with existing data if available.
- Ensure the accuracy of specifications, methods and C of A’s etc. that are generated from the system.
- Provide system training to end users and other departments.
- Support LIMS for Chemistry/Stability, Microbiology and Method Validation Labs.
- Coordinate LIMS training program.
- 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 any Corrective and Preventive Actions (CAPA’s).
- Initiate, and follow through with actions required to close Change Controls.
- Participate in Internal, Customer and Regulatory Audits.
- Provide administrative support to the team.
- Prepare System oriented SOPs/WI and provide review for new system.
- Participate in LIMS validation process as required.
- Identify and implement key process improvements to areas to enhance systems, gain site efficiencies and elevate GMP requirements based on industry best practices and regulatory requirements.
- Works with other departments to proactively build quality into the processes and systems.
- Other duties as assigned.
- Minimum two (2) years of relevant experience in a pharmaceutical laboratory environment.
- Strong chemistry and quality control skills
- Experience with JAVA programming language
- Proficiency in computer programs including Microsoft Office, Databases, ERP systems
- Working knowledge of LIMS &other GXP E-Systems is an asset
- Ability to work independently with minimal supervision.
- Knowledge of cGMPs, FDA, Health Canada and other regulatory requirements (FDA 21CFR part 11 & ICH regulations)
- Good written and verbal communication skills
- Strong organizational skills and ability to multi-task; detail oriented.
- Well-developed interpersonal and teamwork skills
- Experience working directly with computer systems preferred
If you are interested in this opportunity, please submit your resume to firstname.lastname@example.org referencing LIMS QC Coordinator 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.