1. Ensuring good quality non-clinical services like infection prevention, security, diet etc.; 2. Ensuring clean surroundings, OPD Areas, Wards, Labour Room, OT and Patient amenities and outsourced services; 3. Periodical assessment of hospitals on quality check list and arrive at a score for the facility

Must have exposure of working in a sterile manufacturing unit.• The candidate should have experience in both QA Validation and QMS.• Hand on experience in Qualification and validation of equipment, utilities, facility and systems with team management capability.• Well versed with handling the qualification and validation activities for green filed project management.• Good personal and professional management skills for coordinating with different teams across departments the group at corporate level for smooth handling of timely project execution• To review of URS, FAT, SAT, Impact assessment, Risk Assessment, DQ, IQ, OQ, PQ and other Qualification documents.• Updating / preparing site master validation plan.• To perform the FAT for applicable equipment and utilities.• Responsible for process validation and cleaning validation of different products proposed for manufacturing.

Summary: Oversees the laboratory quality control testing of in-process samples, sampling of utilities and manages the environmental monitoring program.Essential Duties and Responsibilities include, but are not limited to, the following:• Manage a team of laboratory analysts within the QC microbiology department involved inthe analysis of intermediates (in the process) and bulk drug substance in a cGMP regulatoryenvironment. Distribute workload and monitor progress.• Manage the environmental monitoring program, including surface, settling, and viableand non-viable particulate air monitoring of aseptic operations and controlled areas• Manages product testing to ensure efficient and compliant operations.• Ensure that all work carried out is in compliance with the required regulatory standards,conforms to company policies and standard operating procedures (SOPs).• Review and approve method protocols, reports, and SOPs.• Assist in the preparation for internal/customer/regulatory inspections.• Ensure a safe working environment within the laboratory.• Proactively identify and implement lab process improvements, lean initiatives.• Oversee or conduct laboratory investigations and generates reports in response toinvalid assays, Deviations, OOS/OOT.• Ensure that CAPAs and Change Controls are initiated and completed on time and inaccordance with site procedures.• Present analytical data reports clearly and concisely to senior management, including QCperformance metrics and trends.• Ability to train, develop and mentor direct reports and effectively manage theperformance of individuals.• May be required to work shift

Manage documentation related to Quality System guidelinesManage and maintain the company’s quality inspection and product release programs for incoming and in process materials and components, processes and finished goodsMaintaining and enhancing the quality of the finished product that is manufactured in the companyImplementing the quality standards set by the company and even by lawEducate the new fellow technicians regarding the procedureAbility to work effectively in a teamEffective Communication SkillsAwareness of G M P guidelinesDeveloped proficiency in attending USFDA, KFDA and Customer Audits

Summary: Validate/qualify equipment, systems, & processes in accordance with regulatory requirements & support, follow & implement company manufacturing standards policies & procedures.Essential Duties and Responsibilities include, but are not limited to, the following:• Responsible for all aspects of the Cleaning Validation programs onsite for a large scale Bio-pharmaceutical Drug Substance production facility.• Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.• Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.• Reviews, edits and approves change controls, SOPs, reports and other documentation.• Collaborates with functional departments to resolve issues.• Trains/advises less experienced Specialists..• May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.• Manage and drives projects and prepares status reports.• May present at both internal and external (regulatory) audits• Stays current with industry trends, regulatory requirement updates, and communicating same to team• May manage full time employees and/or contingent workers.• Performs other duties assigned by Management.• Some travel may be required.This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry.

PE Global are currently recruiting for a Compliance Specialist for a client site in CorkActivities Within Role:Leads GEMBA walk downs frequently, ensuring that areas are always audit ready. Through collaborative and open dialogue, coach area owners in the compliance requirements. Assist them in formulating corrective plans where required, putting a process in place, confirming that actions are addressed.Ensures the highest Quality, Compliance and Safety standards. The Compliance Specialist helps to mold the culture to one that supports a High Performance Organisation.Primary Activities/Responsibilities:Supports the Vaccine IPT compliance plan & generation of quality metricsComplete review & approval of IPT documentation · Tracking & directing follow-up activities, to correct any non-conformity· Leads GEMBA walk downsParticipate in the preparation & hosting of regulatory & customer auditsGMP training delivery to IPT personnelInvestigation of Minor DeviationsProvide Compliance guidance to Operating proceduresReview Deviation Trends & identify effective CAPA’s, where necessaryMember of the site Permanent Inspection Readiness (PIR) team, ensuring that the Vaccine IPT department is Permanently Inspection ReadyProactive monitoring of CAPAs, to ensure holistic trends are proactively resolvedParticipates in the overall CAPA effectiveness program & continued improvement on root cause analysis & follow-up CAPAParticipates in Quality Risk Management· Optimizes existing operations & practices with a focus on continuous improvement initiativesJob Experience:· Knowledge of & experience in applying Lean Six Sigma & Lean methodologies (e.g. 6S)Relevant GMP standardsThe Quality SystemSite procedures & policiesUnderstands key business drivers & uses this knowledge to make decisions & priorities

Specific Job Duties:• With a high degree of technical flexibility, work across diverse areas within the lab• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.• Report, evaluate, back-up/archive, trend, and approve analytical data.• Troubleshoot, solve problems, and communicate with stakeholders.• Initiate and/or implement changes in controlled documents.• Participate in audits, initiatives, and projects that may be departmental or organizational in scope.• Write controlled documents, perform assay validation, and equipment qualification/ verification.• Introduce new techniques to the lab, including method transfers, reports, validations, and protocols.• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.• Approve lab results• May participate in lab investigations.• May provide technical guidance.• May train others.• May contribute to regulatory filings.• May represent the department/organization on various teams• May interact with outside resources.Knowledge:• Experience in a wide variety of analytical techniques including but not limited to HPLC, Gels, Capillary Electrophoresis, pH, Appearance, Colour, Clarity, Sub Visible Particle testing, Osmolality, Protein Concentration, Polysorbate, Moisture, and Device testing.• Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning.• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.

Job Responsibilities:• Lead and co-ordinate all activities within the remit of the Stability team. Responsible for day to day activities of the team.• Represent QA Stability at product, technical and robustness team meetings and lead/drive all associated support activities.• Participate in cross-functional teams as required where strategic leadership is required.• Challenge and develop talent QA Stability team.• Appropriately delegate workload to drive project timelines in a compliant manner, based on experience, knowledge and history of previous projects. Identify strengths and talents within the team drive this delegation.

Candidate must have three to five years of expereince in qualit assurance at a reputed Healthcare organization and must have a Bsc with a B Pharma or MSc with a M Pharma