Analyst, Quality Control Development

Job purpose

The main responsibility for this position is to perform method development, validation and transfer activities to support quality control development department.

Duties and responsibilities

• Perform Assay and Related Substances method development and validation study using HPLC, GC and other instrumental techniques.
• Ensure timely completion of routine analysis for bulk, finished products, exhibit batches, and stability samples.
• Prepare protocol, test method and report related with method validation and method transfer studies.
• Conduct method verification, compendial update & method transfer activities.
• Identify and implement key process improvements to enhance systems, improve efficiency, and meet GMP requirements.
• Ensure Out-of-Specification (OOS), Out-of-Trend (OOT), and Corrective and Preventive Actions (CAPAs) are completed within defined timelines.
• Assist the Manager/Supervisor in qualifying an alternate vendor as per the current SOP.
• Collaborate cross-functionally to proactively build quality into processes and systems.
• Create and revise Quality Control (QC) procedures as required.
• Provide support during internal and regulatory Inspections.
• Generate, compile and analyze data for reporting purposes.
• Complete all GMP documentation correctly and in a timely manner.
• Initiate and follow through on actions required to close change controls.
• Participate in Internal, customer and regulatory audits.
• Maintain a clean and safe laboratory environment, adhering to all safety regulations. 
• Complete all assigned training and maintain up-to-date personal training records.
• Demonstrate flexibility to work shift schedules as required.
• Support peer review of analytical data.
• Perform other duties as assigned by the manager.

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 in Chemistry or a related discipline (minimum requirement).
• 5-7 year of experience in Assay & Impurities method validation study in a pharmaceutical laboratory.
• Expert knowledge of analytical chemistry and instrumentation.
• Proficiency in analytical techniques such as UV-Vis, IR, HPLC and GC.
• Familiarity with software systems including LIMS, Empower, SAP, Trackwise and Microsoft Office.
• Strong understanding and application of Health Canada and FDA regulations.
• Excellent written communication and report writing skills.
• Advanced troubleshooting and investigative skills for analytical issues.
• Ability to recommend changes and initiate investigations when necessary.
• Recommends changes and requests investigations where required.
• Knowledge of In-Vitro & Cleaning validation study is considered an asset

Working conditions

• Ability to work under stressful conditions and changing priorities
• Ability to support work in other shifts
• Numerous and varied responsibilities demanding attention and detail
• Working in general office and laboratory environments

Physical requirements

Office based

This posting is for an existing vacancy.

The presently-anticipated base compensation pay range for this position is $71,000 to $86,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; RRSP savings plan; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, ethnic origin, citizenship, ancestry, sex, age, marital status, family status, physical or mental disability, gender identity, gender expression or any other ground protected by applicable human rights legislation.

The Company does not use artificial intelligence to screen, assess or select applicants.

Notice to Agency and Search Firm Representatives:   Sun Pharmaceuticals Industries, Inc. (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.  Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun.  No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.