Nesher Pharmaceuticals (USA) LLC

Site Compliance Manager Jobs at Nesher Pharmaceuticals (USA) LLC

Site Compliance Manager Jobs at Nesher Pharmaceuticals (USA) LLC

Sample Site Compliance Manager Job Description

Site Compliance Manager

summary

Responsible for performing key compliance projects such as gap assessments to ensure compliance with regulatory requirements. Drive a culture of compliance throughout the organization and promote various compliance policies and procedures. Provide an oversight role to manufacturing and packaging operations.

 

essential Duties and Responsibilities

    • Provide comprehensive formal and informal leadership to promote a positive work environment and communicate overall business expectations to the plant working groups.
    • Verify the compliance status at site for all site functions as per GMP.
    • Interface with all areas of the plant and all levels of management.
    • Report the observations and compliance issues to manufacturing head with a copy to site QA head and CQ lead.
    • Manage Quality initiative improvement projects.
    • Monitor the CAPA tracker status and update the tracker after verification.
    • Support the site for preparation to all external audits.
    • Keep track of observations and compliance status.
    • Train and facilitate the site personnel on CQ practices, standard practices and directives.
    • Ensure implementation CQ policies, standard practices and directives at site and verify compliance.
    • Support site for the preparation and review of response to regulatory, customer, SME and corporate quality audit observations.
    • Review compliance of response to regulatory agency and track compliance to commitments made in the response.
    • Suggest area of improvement in product quality and GMP/GLP enhancements at the site and prepare suitable proposals.
    • Notify management on any observations that impacts product quality.
    • Ensure adherence and closure of commitments provided to regulatory and external agencies.
    • Coordinate for preparing the audit response following a customer audit, regulatory audit or corporate audit.
    • Review self-inspection planner and ensure audits as per planner.
  • Ensure that non-conformances, deviations, customer complaints, and other quality related issues are investigated in a timely manner and corrective/preventive actions are assigned and completed as required.

 

    • Evaluate applicability of identified global CAPA for the site, assign responsibilities and target dates, track and verify the implantation status of the CAPA.
    • Maintain state of control at the site, monitor compliance, identify compliance and product quality issues and champion permanent solutions.
    • Build and maintain a staff of professional, highly motivated and knowledgeable individuals. Participate in selection of personnel and provide for their effective and thorough training. Establish standards of performance in accordance with company guidelines and evaluate performance against those standards for all staff members, to include preparing and conducting performance evaluations.
    • Responsible for implementing company quality ethics policy for data integrity and inform management and responsible data integrity compliance head on any data integrity issues as per corporate data governance policy.
  • Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.

 

  • Perform other related duties as assigned to meet departmental and Company objectives.
  •  

KNOWLEDGE/SKILLS/ABILITIES

  • Detailed working knowledge of Quality Systems, cGMP regulations and compliance.
  • Proven communication skills to communicate in a clear, concise manner whether in oral, written or presentation form.
  • Strong interpersonal skills to effectively establish and maintain collaborative cross-functional working relationships with all levels throughout the organization and outside business partners.
  • Strong organizational and coordination skills to effectively manage multiple priorities, projects, duties and tasks concurrently.
  • PC proficiency using Microsoft Office Suite.

 

EDUCATION/EXPERIENCE

  • Bachelor's degree in sciences or engineering, or related technical discipline; or the equivalent in related education and pertinent and progressive experience, with increasing levels of responsibility.
  • Minimum five years' progressive experience in pharmaceutical or other highly regulated industry.Work environment
  •  

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

  1. Stand, walk, sit, balance, stoop or crouch, kneel, reach, push, grasp, feel, talk, and hear.
  2. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
  3. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects.

 

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

  1. Individual is in a proximity to moving mechanical parts and exposure to chemicals.
  2. Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

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