Stability & Validation Leader – Global Pharma
Australia, Victoria
Full Time
12/11/2020
  • Permanent Leadership Role with Multinational and Innovative Organization
  • Lead Stability & Validation Team as a part of Analytical Services Operations
  • Family Supportive, Friendly Work Environment & Onsite Parking

 

CLIENT

Our client is a well known, multimillion-dollar, global pharmaceutical company that produces a range of Prescription and OTC Medications for both their own brands and those of strategic international partners. Based in South Eastern Melbourne, they continue to grow by investing in developing and commercialising new products. Adding to their range, they assist Medical Practitioners and Pharmaceutical Retailers in generating positive patient outcomes.

 

ROLE

Due to restructuring, our client requires a motivated professional with several years’ industry experience in a similar role in pharmaceutical manufacturing. The ideal candidate will have a tertiary qualification in science, or a related discipline plus an in-depth knowledge of Validation & Stability Programs together with relevant regulatory and compliance requirements applicable in a GMP facility.

Our client promotes a relaxed, family-supportive environment, where proactive and driven employees are well regarded.

If you are looking for a leadership opportunity within a global company that is involved in the manufacture of innovative products, apply now!

 

RESPONSIBILITIES

Reporting to the Laboratory Manager, Validation & Stability Leader will be responsible for all aspects relating to method development, validation, and transfer activities. In addition, the person in this role is required to lead and manage all facets of the stability programs and directly manage three Senior Stability and Validation Coordinators.

Some main responsibilities include:

  • Manage all Validation work activities using HPLC including method development, method validation, and method transfer
  • Ensure product development and transfer projects are successfully executed within the set timelines
  • Ensure appropriate test methods are assigned to test protocols
  • Oversee the development and authoring of study protocols
  • Ensure validation studies are conducted in accordance with protocols
  • Support regulatory requirements and all R&D relevant functions
  • Run the entire stability program and manage daily activities of the Stability Team
  • Review stability data and trending reports generated by the Stability team.
  • Support and develop teamwork within the Validation and Stability Team. Promote great culture, and motivate your team. Inspire and lead!
  • Monitor the progress of Validation and Stability Coordinators and assist in the resolution of technical and performance issues
  • Develop training programs to ensure all direct and indirect reports are appropriately skilled and capable of conducting their assigned duties
  • Ensure that laboratory housekeeping is maintained and 5S standards are adhered to

 

SELECTION CRITERIA

The successful candidate will be a professional with several years’ experience in pharmaceuticals, specifically with Validation and Stability Programs.  You will be experienced at a senior level and possess strong leadership skills.

To be successful in your application you must meet the following criteria:

  • Possess a relevant tertiary qualification in Science such as Chemistry or Biochemistry
  • Hands-on experience with method development, validation, and transfer using HPLC
  • Have a minimum of five years of experience in a similar role(s), specifically within the area of validation and stability programs
  • Experience at a senior level within a pharmaceutical laboratory with strong leadership skills
  • Knowledgeable of relevant regulatory guidelines such as GMP/GLP, ICH guidelines, and compendia requirements
  • Strong project management experience
  • Proven ability to execute final stage reports relating to validation and stability activities
  • Communicate through well-developed interpersonal skills, which promote teamwork and embody leadership qualities
  • Initiative and proactive approach
  • High attention to detail and strong writing skills
  • Highly developed organizational and planning skills, necessary to oversee the above-stated areas
  • Effective written and verbal communication skills

 

APPLICATION

For a confidential discussion about this exciting opportunity please contact Helen on 0438 620 434 or Jo on 0411 197 171.

To apply for this role, please click the Apply Now’ button. Please ensure you send both your current resume and a covering letter, which addresses the above selection criteria, to CS Executive Group.

 

THANK YOU

CS Executive Group would like to thank you in advance for taking the time to apply for this role. Unfortunately, due to the large volume of correspondence our recruitment team receives on a daily basis, we genuinely cannot respond to each application – only individuals being considered for shortlisting as candidates are contacted.

However, if on this occasion you’re unsuccessful, please note your details will be added to our Talent Pool database. This means you may be contacted by one of our team of recruiters for suitable role in the future.