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Join to apply for the AUS_Production Associate role at PCI Pharma Services2 days ago Be among the first 25 applicantsJoin to apply for the AUS_Production Associate role at PCI Pharma ServicesLife changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI.Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.Purpose & DescriptionThe purpose of the Production Associate is to assist in labelling and packaging campaigns in accordance with the Batch Records, Company SOPs and OHS requirements. The Production Associate is also responsible for facility and equipment cleaning and maintenance as applicable. The role requires extensive hands on work and will work closely with other Production personnel, Storage and Distribution, Projects and Quality staff to complete required production activities in a cGMP compliant manner.Primary ResponsibilitiesCompleting company training requirements in accordance with curricula and other training as may be required (e.g. completion of training when SOPs are updated or new SOPs issued that are applicable to production)Ensuring the required Batch Record has been approved and QA issued prior to useEnsuring the required packaging room is ready for use and that appropriate Room logs and registers are completedFollowing the company gowning and hygiene requirementsVerifying the picked released stock and equipment for labelling of clinical supplies and packaging, and assembling kits of finished products in accordance with the Batch Records;Ensuring that samples are taken in accordance with the batch record instructions (e.g. retention samples);Reviewing production batch records and ensuring that these are completed and signed prior to Production Senior Associate review;Ensuring that all deviations are reported to the Production Senior Associate or Associate Manager - Production;Making sure that production facilities are clean and when appropriate, disinfected;Cleaning of equipment in accordance with SOPs;Removing waste materials and rubbish from the packaging facilities and placing in the correct bins;Ensure that calibrations of equipment are performed prior to use and records kept/registers completed;Ensuring that the premises and equipment are maintained and relevant records kept;Reviewing labels and randomisation lists against label approval forms and master randomisation lists prior to commencing batch manufacture;Preparing, reviewing and maintaining SOPs relevant to the Production facility;Participating in PCI internal audits and third party audits and assist in responding to audit findings and product complaints/recalls as may be required;Assisting other departments as requiredQualifications And ExperiencePrevious industry experience and/or Bachelor of Science, Pharmacy or related disciplineExcellent written and verbal skills with good attention to detailDocumented cGMP trainingBehavioural CompetenciesHigh level of professionalism, ethics, quality of work, communication and responsiveness at all timesPositive, can-do attitude, embraces and lives PCIs Vision and ValuesAnalytical thinker and solution finder/problem solverAttention to detailCollaborative, team playerTrusting and trustworthyConscientious and diligentPositive, embraces and responsive to changeJoin us and be part of building the bridge between life changing therapies and patients. Lets talk futureEqual Employment Opportunity (EEO) StatementPCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.At PCI, Equity and Inclusion are at the core of our companys purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.Seniority levelSeniority levelEntry levelEmployment typeEmployment typeFull-timeJob functionJob functionMarketing, Public Relations, and Writing/EditingIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at PCI Pharma Services by 2xSign in to set job alerts for Production Associate roles.Mulgrave, Victoria, Australia 2 months agoAltona North, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 1 week agoApply now! 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