Compliance Engineer

We have an urgent opening for Compliance Engineer   and I have sent you a job description, Please go through it and let me know if you are comfortable with it and also send me your updated resume to mike@sirilan.com.

JOB TITLE :  Compliance Engineer

ESSENTIAL FUNCTIONS

Position reports to the site Compliance Manager.  Primary functions are:

·         Leads and maintains assigned compliance functions to help site sustain a state of compliance to applicable regulations and directives such as FDA Parts 4, 211 & 820, ISO13485, MDD, CMDR, TGA and ANVISA requirements.  Focus for this resource is compliance to 21 CFR Parts 4, 201, 211 for combination products (drug with device).

·         Conducts interim effectiveness checks on combination product related CAPAs and audit observation failure investigations and action plans. Works with a project team as the compliance resource.

·         Assists preparations for and conduct of quality system external audits and inspections. 

 

OTHER RESPONSIBILITIES

 

·         Support Quality Improvement Processes, Projects as assigned.

·         Follows all environmental, safety and health requirements

·         Other department and site projects as assigned by department manager.

 

EDUCATION, EXPERIENCE, & SKILLS

 

·         University/Bachelor's degree in an applied technical discipline.

·         Requires a minimum of 4 years related experience.  Pharmaceutical manufacturing, supply chain or combination products experience required.

·         Current certification of Certified Quality Audit (CQA), Certified Biomedical Auditor (CBA) and/or lead quality systems auditor qualifications preferred.

·         Pharmaceutical and/or Combination products Regulatory compliance knowledge and skills.

·         Interpretation and application of FDA cGMP and ISO Standards

·         Good communication and interpersonal relation skills.

 

Thanks,

Mike

Sr.Recruiter

Sirilan Corp.

E-mail:mike@sirilan.com

Phone:6107071679

www.sirilan.com

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