Employment Spot

Job Description

Our Client â€" A growing Pharmaceutical Co. with WWide sales of $7B and 14K people at their HQ and plant location needs for their Aseptic Mfr.  QA/Validation Dept. Excellent Salary 

Job Posting # 1200- A

Job Title:  Senior QA / Validation Specialist

Location:  Dallas - Fort Worth, TX  Relocation: Partial   Overnight Travel:  5%

Note: Local candidates only or those who can relocate on their own. Some Relocation assistance maybe given by the client.

Company: This is a growing pharmaceutical company with sales of $7+ billion and 14,000 people worldwide.

Group: Be a part of the Quality / Validation group consisting of 14 professionals supporting an aseptic pharmaceutical plant of around 500,000 sq. ft and 400 people. The plant is part of a campus with around 5,000 people that also includes the company headquarters and corporate offices

Department: This position is in 1 of 3 sub-groups responsible for new products / processes which are moved from R/D and product development to full scale commercial manufacturing of aseptic drugs.

Note 1: This QA / Validation position has emphasis on Process Validation with some aspects of equipment and cleaning validation.

Job Description:

50%: Create, review and approve validation / QA documents

30%: Initiate projects for validation of new processes, methods, equipments, etc.

20%: Interface with other groups such as manufacturing, R/D, IT, production, etc.

Responsible for planning and executing multiple assigned validation activities simultaneously, which may include automation, mixing/cleaning, environmental, media program, filter sterilization, autoclave, SIP VHP, ETO and gamma sterilization, as well as significant projects for new lines, new products or process improvement. 

Other responsibilities include completing all validation documents required which meet all internal and external regulations to support product submissions; evaluating state of the art equipment, processes, validation techniques and implementing changes as needed; providing scientific/technical expertise for process improvements and innovative approaches to production and validation activities, including technical improvements and utilization of labor, raw materials and equipment; and participating in establishment resource requirements and executing assigned validation activities within the budget limitations.

• Carry out and perform test functions on an optimum number of studies on a timely basis and prioritize by lessening risk basis.

• Participate in the coordination of efforts of multi-disciplined project team on the design, writing, performance, documentation and approvals of studies.

• Assure high scientific quality of all studies carried out.

• Prepare and gain approval of thorough protocols on a timely basis.

• Provide technical expertise and assistance on manufacturing processes or departments within Alcon.

• Evaluate proposed changes to SOPs and MBRs for compliance.

• Coordinate with technicians and production personnel involved in activities/projects

Job Requirements

Must Have:

• BS in Science or Engineering.

• Minimum 5 yrs experience in pharmaceutical, biotech or medical devices.

• Minimum 3 years hands on experience with QA - Validation in above industries.

  Excellent people and communication skills.   

Nice to have:

• Masters degree

• Broad Process validation experience in any unit operations such as mixing/cleaning, filter sterilization, autoclave, SIP VHP, ETO and gamma sterilization.

• Experience with new products / transfers and aseptic liquid processing.

Keyword: QA, Validation, Aseptic, IQ, OQ, PQ, ASQ, protocols