Quality Assurance
Director/Head

 

Job Number:   #1222

 

Location:   Mountain Time Zone   (relocation assistance provided)

 

POSITION SUMMARY                               (New Position)

 

Essential Duties & Responsibilities

  • Responsible for setting up and expanding the quality assurance function at this facility

  • Responsible and authorized to approve or reject starting materials, packing materials, bulk and finished products.

  • Ensure that the required initial & continual training of plant personnel is carried out, evaluated, and that training needs are identified.

  • Ensure document control W.R.T. Master documents, records, and their retention.

  • Responsible for the approval/authorization of documents like SOP, CoA, Specification, Protocols, BMR, BPR, Formats etc.

  • Ensure compliance with cGMP, statutory requirements, GLP compliance.

  • Ensure approval of deviation, change control, OOS, CAPA, Risk assessment, APQR, Yearly trend, batch release, market complaint investigation and product recall.

  • Ensure effective sampling of Raw Material, Finished, In-process and utility.

  • Ensure In process quality checks including environmental monitoring and plant hygiene.

  • Ensure vendor qualification and management activities.

  • Represent company for regulatory/customer audits in QMS related functions.

  • Conduct audits for qualification of vendor, contract manufacturer, or laboratory.

  • Assign and monitor storage condition for material and products.

  • Ensure stability studies and maintenance of stability chamber inspection.

  • Ensure the calibration and validation of all critical instruments/equipment/utilities are conducted within due date as per master validation plan.

  • Resource allocation such as Quality Assurance person, relevant documents for compliance with GMP related activities.

  • Cross-functional communication for getting the activities completed, i.e., audit report compliance.

  • Facilitate for self-inspection and ensure qualification of auditors for self-inspection, provide training to all auditors.

  • Act, as per various regulations, as the qualified person wherever needed for compliances and batch release.

  • Handover responsibility of batch release including all responsibility to the designated person before taking leave.

  • Ensure all product permission and manufacturing license are valid.

  • Ensure system improvement and team building through continuous improvement through external training.

  • Inform management about the key indicators of section-wise products performance, Market complaint, OOS, changes, failures, Deviations etc.


Education & Experience

  • BS Degree in Engineering or closely related field

  • 15 plus years related pharmaceutical industry experience.

  • Sterile products experience will be a plus.

 

 

 

NEXT STEP OPTIONS:

 

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LINKS TO OTHER JOB DESCRIPTIONS (at this same start-up Facility):
 

Information - This Hiring Project


Plant Manager
Engineering - Director/Head

Quality Control - Director/Head


 

Should you elect to send us your resume, we will never forward it to anyone without first contacting you and receiving your approval to do so.

 

NOTE:   This is an unofficial document prepared by S L Collins Associates, Inc. to provide basic information concerning the position.   The company we are conducting this search for has the official job description.

 

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