Head of Quality Control Operations

4 weeks ago

Fredericton, New Brunswick, Canada SUN PHARMA Full time

Job Title:

QC Team Lead – Regulatory Compliance

Experience:

  • At least eight years of experience in pharmaceutical analytical or Quality Control laboratory settings.
  • Proficient in generic pharmaceuticals with extensive experience in solid dosage form analysis.
  • Strong background in chromatography techniques, specifically HPLC and GC, utilizing Empower data acquisition software.

Summary:

This role reports to the Section Head of Quality Control, and the individual will:

  • Oversee activities related to regulatory compliance, including adherence to pharmacopoeia monographs, general chapters, and FDA guidance pertinent to quality control.
  • Provide troubleshooting assistance to chemists in the QC Laboratory for new product development, ensuring timely completion of activities and enhancing individual performance to meet business objectives.
  • Assist laboratory management in conducting investigations, addressing laboratory incidents, and managing CAPA-related activities to ensure compliance with cGMP standards.
  • Facilitate the execution of analytical method transfer activities for new projects.
  • Prepare and review technical documentation, including reports, gap assessments, and change controls.
  • Offer technical guidance and support to laboratory personnel.
  • This position is recognized as a subject matter expert (SME) role without direct reports.

Duties and Responsibilities:

  • Contribute to the standardization of laboratory processes, ensuring compliance with cGMPs and Standard Operating Procedures.
  • Ensure that established analytical procedures meet current compendia and regulatory standards, and are appropriate for their intended applications.
  • Develop and implement systems, procedures, and training programs to cultivate scientific expertise within the laboratory, ensuring successful project execution in line with industry standards and cGMP compliance.
  • Collaborate with colleagues across various departments and external partners to achieve project objectives.
  • Support analytical method transfer activities for designated projects.

Work Conditions:

  • Work environment associated with manufacturing, production, and warehouse settings:
  • Noise levels may be distracting or potentially harmful to hearing.
  • Exposure to fumes and odors resulting from chemical reactions.
  • Potential exposure to gases such as carbon monoxide and ozone.

The physical demands described are representative of those necessary for successful job performance.

  • Regularly required to use hands for handling, talking, or hearing. Frequently required to stand, walk, sit, and perform various physical activities.
  • Must be capable of lifting and moving objects weighing up to specified limits.
  • Ability to operate equipment such as pallet jacks or Hi-Lo for moving heavy items.
  • Must be able to navigate various work environments while adhering to safety protocols.
  • Must be able to wear necessary personal protective equipment as required.

Qualifications/Education:

  • Minimum of a Bachelor’s degree in Chemistry or a related field; a Master’s degree is preferred.
  • Strong interpersonal and people management skills.
  • Ability to organize complex tasks and oversee staff to ensure timely project completion.
  • Comprehensive knowledge of cGMP compliance.
  • In-depth understanding of USP, EP, ICH, and FDA guidelines.
  • Excellent planning, written, and verbal communication skills.
  • Strong problem-solving abilities.
  • A proactive, hands-on approach with a positive attitude.
  • Intermediate English language proficiency is required.

Compensation and Benefits:

Compensation may vary based on factors such as geographical location and experience. This position is part of the Annual Performance Bonus Plan and is eligible for various employee benefit programs, including medical, dental, and vision coverage, life and disability insurance, retirement savings plans, and paid time off benefits.

EEO Notice:

We are committed to providing equal employment opportunities for all employees and applicants. This policy prohibits discrimination based on various factors, including race, religion, gender, age, and disability.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals does not accept unsolicited resumes from agencies or search firms for this job posting.

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