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SRG's client is seeking an experienced Qualified Person (QP) to join their team on a permanent basis during an exciting period of business expansion.
This position offers an excellent salary and benefits package, making it a fantastic opportunity for a seasoned professional in the field.
The role:
* Perform duties as a Qualified Person in accordance with relevant regulatory directives.
* Oversee Batch Certification and Release of drug products, ensuring compliance with EU Directives and GMP standards.
* Ensure products are manufactured and tested following Good Manufacturing Practice (cGMP).
* Verify that manufactured products meet all regulatory requirements.
* Collaborate with the Quality Director and site management to maintain GMP compliance in line with legislation, policies, and manufacturing authorizations.
* Review and implement Quality Management Systems, ensuring compliance with GMP and regulatory updates; maintain product quality and release standards.
* Serve as a Subject Matter Expert (SME) to support site compliance with Quality Management Systems and assist in regulatory inspections and audits.
* Conduct external audits and support the company's self-inspection schedule.
* Stay updated on current guidelines and regulatory developments for ongoing professional growth.
The person:
* Must be eligible to perform the duties of a Qualified Person.
* Possess a relevant degree, preferably in Chemistry, Pharmacy, or Biological Sciences.
* Have experience with FDA, MHRA, EMA, and other regulatory agencies.
* Previous experience in a pharmaceutical manufacturing environment is required.
* Experience with commercial and Investigational Medicinal Products (IMP).
* Background in sterile products, biologics, and advanced therapeutics, with previous licensing experience being advantageous.
* Willingness and ability to travel for audits occasionally.
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