Process Validation Specialist

Category: Process Development/Sr. Scientist Overview: Monitor/ provide technical support for oral solid dosage validation processes.
Write protocols, execute and write reports for process and cleaning validation.
Develop Validation standard operational procedures.
Ensure compliance with current Drug Enforcement Administration (DEA), Good Manufacturing Practices (cGMP), Andrx policies, and all applicable regulatory agencies.
Write/ revise Master Batch Records.Responsibilities:
Will interact with all levels of the organization, such as Manufacturing, Quality Operations, Engineering, Regulatory Affairs.Job Requirements
Experience:
6Qualifications:
B.S. degree in Pharmacy / Engineering, or Chemistry with 2 - 5 years experience in the Pharmaceutical industry.The candidate must have experience in Pharmaceutical processes/optimization, equipment, validation and technology transfer. Knowledge of SUPAC (Scale Up and Post Approval Changes), cGMPs, and validation guidance is mandatory. Solid problem solving technique is required.
Knowledge, Skills and Abilities: (Indicate the type of knowledge, skills and abilities required, such as verbal and written communication skills, computer skills, technical knowledge, interpersonal skills.)The candidate must have excellent verbal and written communication skills and should be knowledgeable of computers. Good interpersonal and negotiation skills are mandatory.
Will require supervision to perform the job.
Must have good documentation practices.
Knowledge of MS Word and Excel programs.