Executive E-Lab Documentation

Apotex Inc.; Mumbai; On-site; INR 1,200,000 - 1,500,000; Full time

Benefits offered by this job

Disability accommodations

Job summary

Apotex Inc. in Mumbai seeks an experienced LIMS specialist to oversee change controls, documentation, and data integrity across global lab operations.

You will create, revise and review specifications, CofAs, test profiles and analytical methods, ensuring timely posting and regulatory compliance.

Qualifications

• Master's degree in Pharmacy.
• Experience with GMPs governing pharmaceutical documentation.
• Knowledge of SAP, LIMS and TrackWise is an added advantage.
• Strong leadership and problem-solving skills.
• Proficient in Microsoft Office Suite.

Responsibilities

• Create, revise and review LIMS documents for solid dosage, liquid dosage and raw materials.
• Peer review of LIMS data changes for accuracy and compliance.
• Route documents through document management and laboratory information management systems to secure history.
• Coordinate tech transfers from R&D to the commercial environment, including management of Water-mark and release of specifications.
• Update corporate document management and change control systems to reflect revision history.
• Ensure timely posting of LIMS CofAs and Test Profiles to document collections and to external customers as required.
• Develop and maintain expert working knowledge of LIMS functionality through project implementations.
• Collaborate with QC, R&D labs, GIS, Global QC LIMS Business Support, Quality, internal & external consultants on changes.

Skills

Microsoft Office

Leadership

Problem solving

GMP knowledge

Regulatory knowledge

Education

Master's degree in Pharmacy

Tools

SAP

LIMS

TrackWise

Job description

Job Description:

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: www.apotex.com .

Job Summary

• The Executive is responsible for execution of LIMS change controls within Apotex Corporate structure.
• Maintenance of the Global laboratory documentation and data management systems, including the creation, revision of analytical test methods and In-Process Manufacturing & Packaging CofAs, LIMS CofAs and Test Profiles used in the testing & release of commercial and R&D products. LIMS static data for R&D and commercial products, and the assessment of changes for impact to LIMS static data.
• Act as a technical resource and responsible to elevate any critical issues identified during implementation and review of change controls pertaining to LIMS static data changes.

Responsible for product launch readiness and implementation of tech transfer packages for NPD, PLCM, MLCM and site transfers

Job Responsibilities

• Create, revise and review specifications LIMS documents (CofA, Test Profiles)] and Analytical Test Methods for solid dosage, liquid dosage and raw material products in the corporate document management system in response to ongoing change control activities to support Global product transfers and apply harmonized testing policies for Apotex laboratories.
• Perform peer review of documentation and LIMS static data changes for accuracy and compliance with departmental, corporate and regulatory guidelines, and provide feedback as required.
• Issue document numbers for new specifications and analytical test methods.
• Route electronic documents through document management and laboratory information management systems to secure history
• Review new products and map testing requirements to existing analysis inventory list.
• Liaise with QC and R&D labs, GIS, Global QC LIMS Business Support, Quality, internal & external consultants on new developments & cross-divisional changes for configuration, code, reports and projects.
• Evaluate and initiate change controls in support of the creation/revision of specification documents, methods, LIMS master data and LIMS code/configuration.
• Update appropriate corporate document management and change control systems to reflect revision history for new & revised lab documents
• Ensure the timely posting of LIMS CofAs and Test Profiles to the corporate document collections & to external customers as required.
• Develop & maintain expert working knowledge of LIMS functionality through on-going project implementations.
• Coordinate tech transfers from R&D to the commercial environment, including management of activities for the creation of Water-mark and release commercial specifications.
• Ensure timely publishing of all specifications once regulatory NOC approval has been received.
• Perform all work in compliance with current SODs, GSOPs & GMPs.
• Support LIMS projects and initiatives. Represent R&D and QC LIMS static data/document configuration at cross-functional LIMS meetings.
• Develop and maintain effective working relationships with internal and external customers.
• Manage hard copies of LIMS impact sheets, peer review forms and verification forms for timely storage and availability.
• Scheduling and monitoring of LIMS Review day to day activities.
• Work in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values - Collaboration, Courage, Perseverance and Passion.
• All other duties as assigned.

Job Requirements

• Education
• Master's degree in Pharmacy
• Knowledge, Skills and Abilities
• Experience with Microsoft Office applications. SAP, LIMS, TrackWise an added advantage.
• Knowledge of GMPs governing documentation in the pharmaceutical industry.
• SAP experiences an asset.
• Proficient in the use of Microsoft Office Suite applications.
• Demonstrated leadership skills.
• Demonstrated decision-making ability with strong problem solving skills.
• Expert knowledge of all compendia process as it relates to publication and monitoring of changes in the USP, BP and EP.
• Strong knowledge of the ICH guidelines.
• Strong knowledge of regulatory guidelines for FDA and Health Canada.
• Ability to interpret and independently apply broad testing guidelines as per compendia (USP, BP and EP).
• Excellent organizational and interpersonal skills with a customer focus.
• Ability to coordinate and complete projects with strict deadlines.
• Demonstrated ability to work effectively in a team-based environment.
• Ability to adapt in a rapidly changing environment.
• Experience
• Minimum 4-8 years in the pharmaceutical industry with an emphasis on Quality Control, Laboratory Information Management System (LIMS) and analytical data interpretation

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.