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.
Overview:
The Technical Operations Associate’s main responsibility is to ensure that operational excellence and efficiency is achieved, and improvements are made to standards as a primary measure of success. In addition, the person will work closely with Production and other key Departments on CI projects ensuring new/updating existing equipment and/or processes are implemented and trained out successfully.
Primary Responsibilities:
Verify ERP generated reports against the production activity stock issuance and accountability through reconciliation.
Perform In-Process Control (IPC) checks and verification that the correct procedures are being followed, and all associated documentation has been completed correctly, focusing on right first-time approach
Action and be responsible for independent approval signatory for production actions in line with PCI procedures
Active involvement in Continuous Improvement (CI) Projects, including improving existing processes and the introduction of new processes and equipment
Conduct On-the-Job Training and/or Assessment for updated or new Processes and equipment
Manage Action items from CAPA’s and Change controls effectively and in timely manner
Participate in and contribute to risk assessments for equipment, processes and safety as required.
Update process steps in Master Batch Records (Packaging) templates as per Change controls
Review MBR processing steps and align with packaging and labelling activity
Generate quality documentation such as, updating existing or creating new procedures and work instructions, to assist with the introduction of new or updated processes and equipment
Any other tasks/ projects as required by your manager.
Qualifications & Experience:
Experience in the manufacturing and/or packaging in the Pharmaceutical Industry
Bachelor of Science, Pharmacuetical, Engineering or equivalent qualification
Excellent English written and verbal skills with strong attention to detail
Strong organizational skills, the ability to multi-task and manage competing priorities efficiently
Computer proficiency in IT systems such as; ERP, MS Office suite of Products (Word, Excel etc.), database management and the ability to navigate the internet.
Working knowledge of PIC/s Good Manufacturing Practices (GMP)
Working knowledge of PIC/s Quality Management System, especially change management
Key Behavioral Competencies:
Strong written/oral and mathematical skills.
Strong organizational skills, the ability to multi-task and manage competing priorities.
Ability to work independently and deal with sensitive and confidential matters.
Ability to be a team-player and work within a cross-functional team environment.
High level of professionalism, ethics, communication and responsiveness
Accountable for quality of work
Positive, ‘can-do’ attitude, embraces and ‘lives’ PCI’s Vision and Values
Collaborative, team player
Excellent interpersonal, written and verbal communication
Self-motivated and achievement orientated
Trusting and trustworthy
Conscientious and diligent
Positive, embraces and responsive to change
Displays Excellent Time management
Ability to display original thinking and creativity
Ability to demonstrate attention to detail
Ability to exhibit sound and accurate judgment
Reporting:
The role reports to the Technical Operations Associate Manager, and will work closely with Production, Project Management, Facilities and Engineering, and Quality.
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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, Equity and Inclusion 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.
