Specialist, Pharma Tech

Sun Pharmaceutical Industries Ltd•Brampton, ON

3d•CA$71,500 - CA$89,500•Hybrid

About The Position

Driven by a bold pursuit of science and fueled by an unwavering commitment to patients, Sun Pharma is a leading global pharmaceutical company, providing high-quality medicines trusted by healthcare professionals and patients. As part of our mission to Reach People and Touch Lives, we deliver Innovative Medicines, Generics and Consumer Healthcare products that improve the lives of millions of people. With a broadly diversified portfolio of products that span multiple therapeutic areas, we improve access to effective, affordable treatments that promote better health and well-being. Reaching People. Touching Lives. Job purpose The main responsibility of this position is to act as the technical lead in the process development and commercialization of new Taro products and to design, investigate, improve, or trouble shoot current Taro processes and products. The individual will also participate in problem solving, process improvement, and other general issues that may arise in a technology transfer or validation.

Requirements

Minimum Bachelor’s Degree in a Chemistry, Pharmacy, Mechanical or Chemical Engineering or related discipline.
Minimum 7 years of related experience specifically in a technical role within formulation development, quality or compounding environment.
Good organizational skills and multi-tasking ability.
Strong communication skills (written and verbal) and proved ability to work effectively in a team environment.
Basic project management skills.
Good computer skills are needed for documentation work, which includes writing of SOPs and technical reports. Working experience with computer spreadsheets and word processing is required.
Knowledge of statistical software.
Good knowledge and understanding of current Good Manufacturing Practices (cGMP).
Non-routine and complex problems: compounding issues, filling issues and other related problems

Nice To Haves

Candidates possessing Master’s or higher-level degrees are preferred.
Experience in a pharmaceutical environment with c-GMP knowledge is preferred.
Experience in a pharmaceutical environment with c-GMP knowledge with exposure to semi-solid dosage forms is preferred.
Good understanding of test methods, data interpretation and inference.

Responsibilities

Responsible for the conceptual design, process development, and technical transfer of new compounding master formulas which include scale-up from an R&D batch size to full commercial size and transfer of products from external sites.
Responsible for MES MBR and PMBAR creation and review
Act as an independent technical lead for product launch, transfer, scale-up and alternate vendor projects within operations.
Lead improvement projects and provide project plans and detailed timelines where needed.
Prepare study protocols and reports, SOPs, validation and equipment qualification documents.
Initiate and manage change requests related to product introductions, SAP setup (Item numbers, Quality Instructions, BPMs, etc.), master formula revisions, process improvements, and SOP updates.
As requested, investigate and review analytical testing methodology, interpret results and provide input to improve existing analytical test methods.
Investigate and report on possible improvements to existing manufacturing processes and prepare investigational lab batches, as required.
Conduct Process Reviews and assess master formula changes for impact to product and validation status.
Assist in identification and sourcing of new equipment, create user specifications, design reviews and purchase specifications to support process and site improvement activities.
Communicate, generate reports, liaison and track projects to fulfill the above principle duties and responsibilities.
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, as required in Internal, Customer and Regulatory Audits.
Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day