BGD_Compliance Technician

at  PCI Pharma Services

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
General Purpose of Role:
Responsible for conducting validation activities for temperature-controlled equipment at the Bridgend Site and ensuring the maintenance and servicing of all temperature-controlled systems. This role ensures the equipment operates in compliance with GMP and GDP regulations, contributing to the safety and integrity of pharmaceutical products stored or processed within the facility.
Main Responsibilities:

Level 1

• Support in continuous improvement initiatives aimed at enhancing equipment performance, validation processes, and maintenance procedures.
• Support internal and external audits, providing evidence of compliance with validation and maintenance requirements.

Level 2

• Actively participate in continuous improvement initiatives aimed at enhancing equipment performance, validation processes, and maintenance procedures.
• Support internal and external audits, providing evidence of compliance with validation and maintenance requirements.

Equipment Validations
The Compliance Technician will perform equipment validation activities, ensuring that all temperature-controlled equipment is fully validated, functioning according to design, and maintaining the correct environmental conditions. The validation process will be conducted in adherence to internal SOPs, validation plans, and industry regulatory requirements.

Level 1

• Preparing protocol documentation in line with Company SOP’s and Validation Plan.
• Performing validation and qualification of temperature controlled equipment.
• Preparing and reviewing validation results data and reports.
• Preparing validation deviation documentation.

Level 2

• Monitor and manage the validation schedule to ensure timely completion of all required activities.
• Investigate equipment malfunctions, deviations, or failures, determining root causes and implementing corrective and preventive actions (CAPA).
• Performing validations of equipment and facilities as required.

Maintenance of Temperature-Controlled Equipment
Performing regular maintenance checks and ensuring all temperature-controlled systems are operating effectively and consistently, in line with regulatory and safety standards. This includes planning and carrying out both preventive and corrective maintenance on critical equipment.

Level 1

• Perform and document weekly, monthly, and as-needed maintenance checks for all temperature-controlled storage areas, ensuring that equipment is functioning correctly.
• Support the operation and calibration of the temperature monitoring system
• Update and maintain the PPM software for all temperature-controlled equipment, keeping detailed and accurate records of maintenance activities.
• Prepare trending data for temperature-controlled areas, analyzing any deviations or trends that could impact equipment performance or product quality.

Level 2

• Responsibility for coordinating the maintenance activities of temperature-controlled areas, ensuring scheduled tasks are completed on time.
• Oversee the calibration and maintenance of the temperature monitoring system, ensuring that it remains compliant with internal standards and regulatory requirements.

Outcomes of Role:

• Ensure all temperature-controlled equipment is validated and calibrated within due dates, maintaining full compliance with company standards and regulatory requirements.
• Contribute to the smooth and efficient operation of temperature-controlled systems, minimizing downtime and ensuring optimal storage conditions for pharmaceutical products.
• Support the overall quality and safety of the company’s products by ensuring that all equipment operates within validated parameters, safeguarding product integrity throughout the supply chain.
• To comply with GMP (Good Manufacturing Practice) /GDP (Good Distribution Practice) regulations
• Perform additional tasks as needed to support the company’s operational and business needs. This includes assisting with projects, urgent maintenance tasks, or any ad-hoc requests that contribute to the overall success of the business.

Join us and be part of building the bridge between life changing therapies and patients.
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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture

• Ensure all temperature-controlled equipment is validated and calibrated within due dates, maintaining full compliance with company standards and regulatory requirements.
• Contribute to the smooth and efficient operation of temperature-controlled systems, minimizing downtime and ensuring optimal storage conditions for pharmaceutical products.
• Support the overall quality and safety of the company’s products by ensuring that all equipment operates within validated parameters, safeguarding product integrity throughout the supply chain.
• To comply with GMP (Good Manufacturing Practice) /GDP (Good Distribution Practice) regulations
• Perform additional tasks as needed to support the company’s operational and business needs. This includes assisting with projects, urgent maintenance tasks, or any ad-hoc requests that contribute to the overall success of the business