Technical Writer

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.

Role Summary:

Reporting to the Production Compliance Manager, this role will provide support to the Production Team ensuring efficient management of system documentation, product quality investigations and GMP compliance.

Primary Responsibilities:

1. Provides support, information and assistance with the initiation, investigation, submission and closure of the following documents:

Operational Events

Management of Change

TER’s

Operational Deviations

Customer Complaints

2. Verify the effectiveness of corrective / preventive actions based on root cause analysis.

3. Through verification corrective / preventive actions identify opportunities for continuous improvement across similar processes and procedures.

4. Assist the Continuous Improvement function to complete root cause investigations into internal packaging department delays.

5. Facilitate reviews of and revise department related documents i.e., SOP's and Logbooks etc

6. Represent the Packaging function in NPI / MOC projects to ensure the necessary documentation is completed, reviewed and communicated as required.

7. Develop, implement and report appropriate KPI’s relating to the role.

8. To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities

Requirements:

1. Minimum 2 years of working with quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs, or related experience.

2. 3rd Level qualification in a Science/Engineering subject preferred but is not essential if relevant experience can be demonstrated working in a Quality or Compliance job role.

3. Successfully demonstrate use of root cause analysis / corrective & preventive action methods.

4. Excellent analytical and critical thinking skills with a record of successfully implementing change management.

5. Maintains knowledge of current Good Manufacturing Practices.

6. Excellent communication skills, both verbal and written.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.