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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Validation Specialist

Job Description

  • Location: New Brunswick, NJ
  • Type: Contract
  • Job #72715

Our client, a leading pharmaceutical company, is hiring a Validation Specialist on a contract basis.

Work Location

New Brunswick, NJ

Summary

1. Manages CMO relationships from a quality and compliance perspective, including monitoring quality metrics, performing annual risk assessment of CMOs and executing oversight as defined by Standard Operating Procedures (SOPs), authoring and executing Risk Mitigation Plans as needed

 

2. Determines disposition of drug products according to client and regulatory specifications and standards

 

3. Review change requests generated internally or by External Manufacturer

 

4. Reviews Annual Product Quality Reviews (APQRs) authored by Contract Manufacturers/Packagers and supplement APQRs as required

 

5. Investigate and/or evaluate manufacturing, packaging and laboratory deviations or incidents and associated Corrective and Preventive Actions (CAPAs) and provide direction and recommendations as to future course(s) of action

 

6. Review Quality Agreements

 

7. Review and approve product quality complaint investigations

 

8. Review and approve validation/qualification protocols and reports from the External Manufacturer as defined in related Quality Agreements

 

9. Write, review and implement SOPs to ensure compliance with current client standard and current Good Manufacturing Practices (cGMP)

 

10. Participate as required on Fact Finding Investigation Team (FIT and Fact Finding Investigation Review Meetings (FIRM)

 

11. Supports product recalls and executes plan as assigned

 

12. Represent client during FDA/other regulatory inspections and corporate Good Manufacturing Practices (GMP)compliance audits as defined in related Quality Agreements

 

13. Assist with preparation of audit observations

 

14. Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate client and FDA and European Medicines Agency (EMA) cGMP regulations and policies

 

15. Represent Quality on cross-functional teams within the “Virtual Manufacturing Plant”, Technical Transfer teams, Supplier Selection, Serialization Manufacturing and Packaging launch teams

 

Required Competencies

 

1.Knowledge in solid dosage forms, parenteral technology, biologics or combination products

 

2. Knowledge of compendial and cGMP requirements, FDA regulations and the ability to interpret and apply them

 

3. Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control and Archiving (DCA))

 

4. Good verbal and written communication skills essential

 

5. Excellent interpersonal skills

 

6. Capable to manage multiple priorities

 

7. Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met8.Trained in auditing techniques and skills such as observation, questioning, and assessment of complex problems

 

Required Qualification(s) and Desired Experience

 

1. B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent

 

2. A minimum of five (5) years experience in pharmaceutical, biologics, biotech or related industry with relevant experience

 

3. Experience in a Quality Assurance, Quality Control or equivalent function is required

 

4. Experience in the manufacture of drug substance and/or drug product or quality control laboratories is desired

 

 

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