Compliance Officer
Pharm-Olam
Bangalore, IN
20h ago

Overview

About Pharm-Olam International :

Pharm-Olam International is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace.

Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further.

We offer a unique working environment with a global team culture, competitive salary and benefits package.

Summary :

Responsible to make decisions and follow through on actions that maintain and improve the quality systems and operational quality within Pharm-Olam.

Responsible to support Compliance in execution of : Inspection Readiness, Case Management, Controlled Standards Management, Risk Management, and Process Improvement while fostering compliance through education and communication with all Pharm-Olam employees.

Performs duties with minimal supervision, whilst helping to improve process standards.

Responsibilities

  • Execute strategies to meet company goals set at the Director level and above.
  • Investigate deviations, complaints and audit findings, providing solutions to ensure company survival and growth.
  • Provide Stategic advice to employees that enables them to meet company compliance goals and requirements.
  • Maintain consistent oversight of cases managed in the IEQMS, providing guidance and motivation to drive maximum performance.
  • Internally Communicate and build relationships with colleagues at all levels, ensuring access to Pharm-Olam interpretations of regualtions and guidance.
  • Externally Communicate and maintain trust relationships with shareholders, business partners and authorities.
  • The incumbent will be responsible within the areas of competence listed below :

    Case Management

    1) Creation of corrective and preventative action plans (CA / PA), tracking, identifying trends, facilitating discussion and applying expertise in investigations and effectiveness evaluations, through to closure.

    2) Guiding and assisting all staff in completion of cases management within the IEQMS in a timely manor resulting in high quality responses to audit results, deviations and complaints.

    3) Providing trended analysis of case data regularly, used to prioritize improvement recommendations

    Inspection Readiness :

    1) Planning, preparing, coordinating, hosting and agreeing responses of sponsor and regulatory inspections or audits at Pharm-Olam facilities.

    2) Preparation of functions and offices in their preparation for inspection or audit.

    Controlled Standards

    1) Maintenance of controlled documentation system, guiding the review of SOPs and associated documents (and associated training) as elements of the Quality System for continuous improvement and ongoing compliance.

    Risk Management

    1) Maintainance of risk management schema which utilize appropriate key performance indicators (KPIs).

    2) Development and Maintenance of Risk Registers, Bowtie risk assessments, and associated control effectiveness.

    3) Coaching all staff in the development and use of the Bowtie risk assessment methodology

    Process Improvement

    1) Coordination of quality and compliance data, working to provide demonstrable operational and financial efficiencies through Practical Process Improvement (PPI) while maintaining and reinforcing compliance.

    2) Identification of problem areas based on data and trends of overall system functions.

    3) Provision of guidance for all staff in the use of practical process improvement tools and methods.

    Working Relationships :

  • Reporting to the Director, Compliance
  • Interaction with all groups within Pharm-Olam and our subcontractors.
  • Liaison with QA / project staff at Sponsor organizations.
  • Qualifications

  • Minimum experience of 4-8 years in a GCP environment, ideally 2-5 years experience in : case management (CA / PA) inspection readiness, quality systems management, training will be considered.
  • Thorough knowledge of ICH / FDA / GCP Regulations / Guidelines and EU Directives.
  • Excellent communication, interpersonal and leadership skills, with attention to detail
  • Bachelor’s or Master’s degree in a healthcare / scientific discipline relevant to the activities to be conducted is necessary;
  • or a combination of education and experience.

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