Quality Assurance Specialist

3 weeks ago

Fredericton, New Brunswick, Canada SUN PHARMA Full time
Job Summary

Sun Pharma is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our Quality Assurance department, you will be responsible for performing critical in-depth reviews of scientific data for Quality Control laboratory documents.

Responsibilities
  • Conduct thorough reviews of raw data, including in-process, API/Excipients, Finished Products, Stability, Cleaning Verification, Instrument calibration records, Contract laboratory results notebooks, reports, and materials for ANDA submissions.
  • Demonstrate a deep understanding of approved SOP's, compendia (USP, BP, and EP), ICH, FDA, and other regulatory guidances.
  • Ensure that all documents are in compliance with cGMPs and the site operating procedures.
  • Support systems to ensure the successful completion of Departmental goals and objectives.
  • Perform other tasks as assigned by the Manager.
Work Environment

This role requires frequent sitting, use of hands to finger, handle objects, or feel objects, tools, or controls, and reaching with hands and arms. Occasional visits to the lab environment, standing, and stooping, kneeling, and crouching may be required.

Requirements
  • Minimum of a Bachelor's degree.
  • Knowledge of pharmaceutical analysis.
  • Ability to review laboratory records with minimal supervision within the framework of cGMP/GLP for analytical laboratories.
  • Good understanding of EHS and OSHA safety guidelines.
  • Knowledge of USP, ICH, FDA, and DEA regulations.
  • Knowledge of the operating principles of HPLC, UV, FTIR, GLC, and Malvern particle size analyzers.
  • Demonstrated excellent communication: verbal, written, and presentation skills.
  • A self-starter with a hands-on approach and a can-do attitude.
  • Intermediate-B1+ level of English language proficiency.
Experience
  • Minimum of three years of experience in a pharmaceutical environment with a minimum two years of experience in chromatography (e.g. HPLC with empower data acquisition software, GC, FTIR, UV, and wet chemistry).

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, and may be eligible for the Employees are eligible to participate in Company employee benefit programs which include medical, dental, and vision coverage; life insurance; disability insurance; (k) savings plan; flexible spending accounts; 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, employee will be in an "at-will position" and 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, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics, or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

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

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