Laboratory Manager – Validation & Documentation

Laboratory Manager – Validation & Documentation

• Senior Leadership Role with Global Pharma
• Lead, Manage & Coach the Validation & Documentation Teams
• State of the Art Facilities, Friendly & Supportive Work Culture

 

CLIENT

Our client is a well-known TGA licenced pharmaceutical company that manufactures Prescription and OTC Medications. Boasting state of the art facilities, they provide a supportive environment, where proactive and driven employees are acknowledged and rewarded.

 

ROLE

This opportunity is available as our client wishes to realign laboratory operations for accuracy and efficiency gains in support of best-in-class manufacturing. They require an outgoing and energetic professional with experience in a leadership role within pharmaceuticals – human or veterinary, or other highly regulated environments such as those that are TGA/APVMA licenced. Working closely with other senior managers, you will be able to contribute to organisational change management through the development of tools, systems and processes, whilst guiding and mentoring your staff through this period.

 

RESPONSIBILITIES

The Laboratory Manager – Validation & Documentation has a team of professional scientists including two direct reports and several technically proficient analysts. You will be responsible for the overall management of the Validation and Documentation functional work activities, resourcing, and scheduling, technical problem solving including establishment and maintenance of documentation for all laboratory activities.

The ideal candidate will have in-depth knowledge of Validation Programs and relevant regulatory and compliance requirements applicable in a GMP, TGA or APVMA licenced facility.

You will be accountable for the management and ultimate approval of all aspects relating to HPLC method development, validation, transfer activities, investigations and relevant documentation. You will manage projects and provide your team with the tailored training and coaching required to increase their capabilities and efficiency, and ultimately their job satisfaction.

Other responsibilities include:

• Inspire and lead! – Support and develop teamwork, promote a great culture, and motivate your team.
• Ensure product development and transfer projects are successfully executed within set timelines
• Oversee the development and authoring of study protocols, and including finalising technical reports
• Monitor the progress of Validation activities to assist in the resolution of technical and performance issues
• Ensure Documentation is conducted for all Laboratory activities to the requisite standard and timing
• Mentor and coach staff including conduct of annual performance reviews
• Develop training programs to ensure all direct and indirect reports are appropriately skilled and capable of conducting their assigned duties

 

SELECTION CRITERIA

We are looking for a manager with excellent people and project management skills. You will be positive, energetic and personable and enjoy leading.

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

• Relevant tertiary qualifications in Science
• Proven leadership skills and experience in a similar role, specifically within the area of validation
• Excellent verbal and written communication in English
• Resilient and highly professional with the ability to communicate at all levels of the business
• Strong interpersonal skills, initiative and a proactive approach
• Strong project management experience
• Past or recent hands-on experience with method development, validation and transfer using HPLC
• Knowledgeable of relevant regulatory guidelines such as GMP/GLP, ICH guidelines, and compendia requirements
• Proven ability to review and execute final stage reports relating to validation activities
• High attention to detail
• Highly developed organizational and planning skills, necessary to oversee the above-stated areas

 

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, only individuals being considered for shortlisting as candidates will be contacted.

However, if on this occasion you’re unsuccessful, please note your details will be added to our Talent Pool database.