Job description

Cliantha is currently seeking a Systems Validation and Compliance Manager who can fulfill its business needs and is looking for better learning and growth opportunities.

About Us

Cliantha Research is a full service Clinical Research Organization (CRO) that provides comprehensive and integrated offerings in Early Phase, Late Phase, Respiratory, Tobacco Research, Dermatology, Consumer Research, Research Lab, IVRT, Biometrics, Pharmacovigilance & Medical Services, and Environmental Exposure Chambers (EECs).

With several advanced clinical sites and bio-analytical laboratories in North America and India, Cliantha now has presence in 4 countries along with a strong team of 1000+ professionals. Some of the key regulators, such as the USFDA, EMA, AGES, ANSM, AMPS, MCC South Africa, Health Canada, DCGI, CAP, NABL, Turkey MOH, Thailand MoPH and others have successfully inspected Cliantha across the globe.

Cliantha Research is headquartered in Ahmedabad and has expanded its domestic presence with 5 regional offices & international presence with offices in USA (Florida & New Jersey), Canada (Mississauga, Winnipeg & Scarborough) & Europe (Portugal).

Primary Responsibilities:

The Manager, Systems Integration is responsible for Supervising, coaching and developing departmental staff for supporting Equipment and Computerized system quality and compliance as well as coordinating the work of the Validation / Metrology group to ensure that computerized system and equipment are validated, qualified, maintained and calibrated properly on schedule, complying to appropriate guidelines / specifications and internal procedures. Maintain the IT quality system to ensure compliance with internal / external regulatory requirements. Provides leadership in strategy and administration of internal and external programs and processes related to validation activities and metrology for the Inflamax. Develops calibration methods and techniques based on principles of measurement science, technical analysis of measurement problems, and accuracy and precision requirements. Develops validation protocols meeting industry standards for computerized system, equipment, utilities and processes to ensure Inflamax’s regulatory compliance in support of client end use. Additionally, creates and revises Standard Operating Procedures (SOPs).

Qualifications:

· Bachelor of Science in Engineering or equivalent

· 8+ years of relevant work experience in biotech/Pharmaceutical industry including general knowledge and understanding of inspection equipment, procedures and 5+ years of direct experience with compliance and computer systems validation.

· Experience with GxP regulatory requirements including validation and 21 CFR 11 compliance of computer systems.

· Experience with GAMP 5, risk-based approach to compliant GxP computer systems.

· Familiarity with business processes in clinical, regulatory, manufacturing and supply chain operations.

· Strong analytical and problem solving skills

· Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively

· Excellent interpersonal skills

· Strong written and verbal communication skills

Why Cliantha Research?

· Competitive Salary.

· Medical, Dental, Vision, and Life Insurance.

· An exciting opportunity for learning and development!

Cliantha Research is committed to creating and maintaining a diverse, inclusive, and accessible environment for all its employees and clients. We value diversity at workplace and believe in fostering a spirit of excellence brought in by all our employees and clients. If you require accommodation before, during, or after the interview/recruitment process do not hesitate to let us know when we contact you and we will work with you and do our level best to meet your needs.

We thank all our candidates for taking interest and the time to apply for stated job vacancy; however only those selected will be contacted for next steps.

Job Types: Full-time, Permanent

Schedule:

• 8 hour shift

Experience:

• compliance and validating computer system: 1 year (preferred)
• Biotech/Pharmaceutical: 1 year (preferred)

Job Type: Full-time

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Mississauga, ON: reliably commute or plan to relocate before starting work (required)

Experience:

• Systems Validation and Compliance: 2 years (preferred)

Work Location: One location

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