Coordinator, Quality Assurance

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 for this position is to provide support for site-wide Quality Assurance Programs including GMP Documentation and Change Control to meet SUN Pharma, Canadian and FDA GMP requirements.
This position acts to oversee the processing of GMP Documents including revisions, posting, archival as well as maintenance and storage of GMP documents at the SPCI QA Documentation Center and Third‑party Documentation Storage Facility.

Duties and responsibilities

Organize and coordinate the archival, retention and retrieval of GMP Documentation generated at SPCI.

Support Regulatory Inspections and Customer Audits through the timely retrieval of Documentation

Support revision and posting (making effective) of Quality Control Documents (eg Test Methods, Specifications) and Master Production Documents as per assigned Change Control tasks in a timely manner

Facilitate communication with stakeholders required for completion of Change Control tasks within assigned due date

Support QC, QA and RA Departments by updating specifications, test methods required for regulatory submission as assigned and monitor and support the further implementation when approved by the Agency

Support Production and QA Incoming Departments with maintenance of active and archived Engineering, Packaging specifications and Art Work electronic packets.

Maintain and regularly review GMP Documentation inventory to assure timely closure of document requests, timely transfer of documents for archival at a third‑party storage facility and provide support for timely GMP document destructions

Act as a backup for Specialist, QA (Documentation) as per the business needs

Generate, gather and analyze data to support specified Quality Systems:
Documentation and Change Controls

Generate reports associated with the specified Quality Systems:
Documentation and Change Controls

Perform assigned tasks for implementation of new Documentation related Software systems: eg EDMS, BRMS, as required.

Perform assigned actions related to SUN global projects for documentation updates: eg rebranding of GMP Documentation, Art Work Rebranding.

Participate in Internal Quality Audit and Internal Self‑Inspection Program as assigned

Complete required Department trainings within assigned due date

Identify and report issues required improvements in the area of expertise related to the job duties and propose the enhancement to support the efficiency.

Work with other departments to proactively build quality into the processes and systems

Perform responsibilities in a GMP compliant and safety conscious manner

Other duties as assigned

Additional responsibility (Only applicable to customer facing roles)
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

Qualifications

Bachelor’s Degree or a College Diploma in a Science related discipline

Previous experience in the pharmaceutical Industry in a Quality / Documentation Coordination Role is preferred

High Proficiency in MS Word and Excel

Sound knowledge of Health Canada and FDA regulations

Good verbal and written communication skills

Ability for Critical thinking and analyzing

High attention to details and ability to stay focused when multitasking

Ability to establish and prioritize daily work schedules in a fast‑paced environment.

Ability to work independently and under minimum supervision.

Ability to identify discrepancies, deviation form procedures, issues related to completion of tasks and brought to the attention of…