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 Laboratory Technology Analyst (LIMS) to join our Quality Control Department.
The main responsibility of this position is to be the leading expert in the building of logic and processes in LabVantage LIMS for Quality Control (QC) department to operate a compliant paperless laboratory. The responsibilities will include building Master Data and automating process flows in LIMS LabVanatage using JAVA and Groovy, in addition to being the key technical leader and directing the LIMS Team. This includes verification of Master Data prior to activation, troubleshooting Master Data issues during operational use by the QC laboratory and developing new process flows to meet QC needs. The candidate will also provide technical support and training for new LIMS Coordinator’s and QC end user training.
Principal Duties and Responsibilities :
- Understand Good Manufacturing and Laboratory Practices in the Quality Control Department, the Laboratory Technology Analsyt will look to maintain compliance with the regulatory agencies and best GMP/GLP practices.
- Understand and Communicate out the requirements for compliant documentation in paperless LIMS laboratory.
- Understand interface requirements to compliantly document laboratory data from instruments into LIMS.
- Process changes of varying complexity to existing LIMS Master Data
- As the Technical Expert, guide the team in building interfaces between LIMS and equipment generating electronic data.
- Support the troubleshooting of LIMS issues observed during production use, on the floor with the QC laboratory and while generating Master Data in the development phase.
- Proactively update LIMS SOPs and training programs to ensure compliance with regulations.
- 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 and review static data (specifications, methods, etc.) in LIMS.
- As the principal Technical expert generate the standard that the team follows in validating Master Data by challenging at extremes and borderline with existing data if available.
- Ensure the accuracy of specifications, methods and CofA’s etc. that are generated from the system.
- Provide system training to the LIMS team, end users and other departments.
- Support LIMS usage for Chemistry, Stability, Microbiology and Method Validation Labs.
- Perform system internal audit when required.
- 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 and Work Instructions 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.
- Work with other departments to proactively build quality into the processes and systems, especially with computer systems validation, information technology and quality assurance.
- Other duties as assigned.
Knowledge, Skills and Abilities
- A minimum of 2 years experience in a pharmaceutical laboratory required.
- A minimum of 2 years experience using LIMS is required, with LabVantage experience preferred.
- Experience working directly with computer systems preferred
- Strong chemistry and quality control skills, following current GMPs.
- Experience with JAVA and Groovy programming language or equivalent programming language.
- Proficiency in computer programs including Microsoft Office, Databases & ERP systems
- Working knowledge of LIMS required and 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
If you are interested in this opportunity, please submit your resume to email@example.com referencing Laboratory Technology Analyst (LIMS) 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.