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If you wish a successful career,we encourage you to submit your resume
                                           Qualified candidates please submit your resume to HR@alpharmapr.com
 
 We are sourcing contractors with strong expertise in the FDA regulated industries such as:
  • Process Validation Scientist: Solid Dosage & Parenterals
  • Cleaning Validation: Manufacturing Process
  • Project Manager
  • Manufacturing Investigations:Solid Dosage & Parenterals
  • Quality Specialist: Method Transfer Knowledge

 


Engineer

Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.  Special needs on 3D modeling using Solid Works and part engineering for projects assigned.

BS in Mechanical Engineering is highly preferable.


 

Sr Engineer(various positions)

Experience in Automatic or Manual Inspection processes is a MUST. Knowledge and experience in the life cycle of design, commissioning and validation of equipment.

BS in Engineering is required. Preferable Mechanical or Electrical Engineering.


 

Sr Validation Scientist

Experience in: Generation of validation protocols. Execution of validation protocols. Review validation documents and SOP's as Data Verifier, author, or owner as applicable.

BS in Life Sciences or Engineering is required and 5 years of directly related experience.


 

Specialist Quality Complaints

Primary responsibilities include: Supporting the product complaint system, leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner. Functions: Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately. Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.

Doctorate degree in Sciences/Engineering or Master’s degree in Sciences/Engineering & 3 years of experience directly related to the job or Bachelor’s degree in Sciences/Engineering & 5 years of experience directly related to the job. Fully bilingual.


 

Engineer

Job Seeker must have experience in; Experience in Packaging Areas, Equipment Validations, Printing Technologies, Experience in Serialization highly preferable.

Education: BS in Engineering is required (excluding Civil Engineering) and 5 years of directly related experience. Working knowledge of pharmaceutical/biotech processes. Familiarity with validation processes. Bilingual: English & Spanish.


  

QA Specialist

Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment.
Fully Bilingual/Documentation Experience.
Bachelor’s degree in Sciences/Engineering and 5 years of directly related experience.


   

Specialist Manufacturing

With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems. Initiate, revise, and approve manufacturing procedures.

BS in Life Sciences or Engineering (excluding Civil Engineering) is required and 5+ yrs of directly related experience.  Availability to work non standard shifts as per business need Experience in: Ensure that all Non-conformances are triaged within the established goal. Responsible for authoring investigation reports. Responsible for execution of corrective actions. Responsible for managing NC/CAPA closure within established goal. Monitor and communicate incidents trends.


Sr Specialist QA

Support Change Control review for completeness/Review Commissioning plan, URS and Design Specification/Review and approval of Validation Plan/Review FAT, SAT and Characterization Documents/Review and approval of IOQ 7 RTM/Review and approval of PQ (protocol & report)/Review Commissioning Summary Report/Review an approval of Validation Summary Report/Review and approve SOP's, Form's and TRnQ's/Review and post approval of Test Runs

Doctorate degree in Sciences and 2 years of directly related experience or Master’s degree in Sciences and 6 years of directly related experience or Bachelor’s degree in Sciences and 8 years of directly related experience

 

 

**Candidates please send your CV-Resume in Word format not PDF**