5 Pharma Operations Jobs

Job role: - To enable organisations emergence as a world class R&D organization, the Site Management and Monitoring (SMM) Country/District COM plays a leadership role accountable for driving the businessof SMM within a Country/District(s) by providing oversight and direction to SMM staff; accountable for the on time, within budget and quality delivery of the clinical studies. - Promotes best practice; - Identifies infrastructural improvements and implements action plan to ensure Clinical Field Operations (CFO) and business objectives are successfully met; ensures alignment of local activities with regional/global initiatives. - The role reports into the Site M&M Leadership and serves as a single point of accountability for the SMM deliverables within a Country/Disitrct(s) and influences and aligns within Development Operations, and with Global Medical Affairs (GMA), and other key stakeholders across the organization. Responsibilities : - Manages/oversees site/country or district related activities as they relate to clinical studies (e.g. country feasibility, site evaluation/selection and activation, contracts/budget negotiation, regulatory/EC submissions startup, issue management, relationship management, monitoring, site closure). - Accountable for the on-time and within budget execution of all clinical trials within a Country /District(s). - Provide local regulatory and legal requirement expertise. - Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. - Monitor regulatory reforms and industry trends within country / region. - Conduct and/or implement impact analysis of all significant changes to conform with updated regulatory / industry regulations affecting conduct of clinical studies. - Always ensures audit and inspection-readiness Country contact for regulatory agency questions related to monitoring processes and procedures. - Drive CAPA preparation and implementation. - Accountable for managing country/district resources including need identification, timely hiring and allocation, and managing changes to hiring plan. Responsible for staff recruitment and retention plans. - Accountable for functional budget planning and administration. - Provide leadership to the Country/District and be accountable for growth and development Qualifications : - Education : Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred. - Experience : 1 5-20 Years - Site Monitoring Experience : Minimum 3 years. Preferably having monitored and/or managed a study within a Country from start to close. - Experience in functional budget planning, resource planning & assignment, quality management in a Country lead capacity preferred. - At least 2 years of experience in line management of staff including acquisition of talent, performance management, growth and development, managing employee relations, coaching and mentoring of staff and teams preferred. - Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making. - Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team player. - Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with experience leading (within country or region) projects with competing deadlines; Experience across multiple Therapeutic Areas and Study Phases.

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief Team/department Description: Technical Operations is responsible for management and oversight of technical process strategy, CMO and CDMO management, and execution of product deliverables in alignment with Azurity policies, Azurity clients and in accordance with company objectives. The position leads staff and / or contractors and collaborates cross-functionally to achieve project milestones in support of process scale-ups and process validation, technical transfers, implementation of lifecycle post approval changes, and investigation / closure of deviations / OOS for commercial products. Principle Responsibilities: - Manage the planning and execution of manufacturing along with associated qualification and validation activities as they relate to both development and commercial products. - In cooperation with contract facilities, manage the review, approval, and execution of controlled documentation concerning late-stage development, qualification, validation, and commercial manufacturing activities as needed. - Direct tasks associated with late stage product / process development (as applicable), product transfers, equipment qualifications, and validation activities to ensure alignment with company policies and objectives. - Support and / or lead product launch and commercialization efforts. - Ensure that appropriate policies, SOPs and documentation are in place to support validation practices according to regulatory requirements and applicable industry guidance documents. - Support Management Review and Compliance related activities as needed. - Assist in preparing metrics and compiling summaries to effectively communicate status and recommendations to Senior Management. - Support Due Diligence activities to support company objectives including product development, technical transfer, commercial manufacturing, and/or commercial launch. - Collaborate closely with cross-functional team members from functions including Supply Chain, Product Development, Quality Assurance, and Regulatory Affairs. Qualifications And Education Requirements: - Bachelor's degree in Life Sciences (Master's Degree preferred), or related field. - Minimum 15 years of experience in biopharmaceutical/pharmaceutical GMP environment or related industry. - Expertise in cGMPs, ICH and Validation related requirements and guidances - In-depth experience in performing technical transfer of multiple dosage forms (solid oral, liquid oral, injectables, etc.) - Experienced in multiple validation disciplines including manufacturing process validation of multiple dosage forms, cleaning validation, packaging validation, analytical methods validation, terminal sterilization validation, hold time studies, shipping studies, equipment / utilities qualification, and facilities validation - Ability to work in a strategic, tactical, and hands-on level. - Candidate must be proficient in Microsoft Word, Excel, and Powerpoint. - Experienced in participating in regulatory agency inspections. - By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.

As the Strategy Manager for PPL's three businesses - PPS, PCC, and CPD, your primary responsibility will be to drive the development of the strategy roadmap and strategic initiatives for the organization. You will work closely with internal stakeholders such as Business Heads, CXOs, Legal, Compliance, Investor Relations, and select Board members, as well as external consultants and investment bankers. Reporting directly to the Vice President of Strategy, you will lead a team of three members. The ideal candidate should hold a full-time MBA in Marketing, Operations, Finance, or Strategy from a Premier B School and possess 5-7 years of experience in strategy roles within the Pharma industry. Consulting experience is desirable but not mandatory. Critical qualities for this role include the ability to work strategically and collaboratively across businesses, proficiency in quantitative and qualitative analysis, scenario planning, and a strong understanding of strategy, pharma operations, M&A, and finance. Effective communication and interpersonal skills are crucial, along with the ability to influence key stakeholders without direct authority. Your key roles and responsibilities will involve driving strategic business initiatives, leading large programs and projects, identifying market trends, developing strategic roadmaps, and long-range plans. You will also be responsible for providing governance practices, creating collaterals for key review meetings, and developing external content for conferences and media interactions. Overall, you will serve as a key liaison between the Executive Committee members and other senior leaders within the organization, ensuring alignment and communication on various business aspects. This role requires a proactive and strategic mindset, strong analytical skills, and the ability to drive execution while fostering collaboration across multiple geographies and functions.,

You will drive the strategy roadmap development for PPL's 3 businesses - PPS, PCC, and CPD along with strategic initiatives of the organization. Your key stakeholders will include internal teams such as Business Heads, Other CXOs, Legal, Compliance, Investor Relations, and select Board members. Additionally, you will engage with external consultants and investment bankers. You will report directly to the Vice President - Strategy and manage a team of 3 members. To qualify for this position, you must hold a Full-time MBA in Marketing, Operations, Finance, or Strategy from a Premier B School. You should have 5-7 years of experience in strategy roles within the Pharma industry, including Corporate Strategy, M&A, and Business Strategy. Consulting experience will be beneficial but not essential. Critical qualities for this role include the ability to work strategically and collaboratively across businesses, functions, and geographies. You should have a strong focus on quantitative and qualitative analysis, scenario planning, and business profitability. A sound understanding of strategy, pharma operations, M&A, and finance is crucial. Effective communication and interpersonal skills are also necessary to liaise with key stakeholders and drive execution and program management. Your key roles and responsibilities will involve driving strategic business initiatives from origination to successful execution in alignment with the business strategy across multiple stakeholders and geographies. You will lead strategically important programs and projects within each of the businesses and/or at the PPL level. Additionally, you will assist the Head of Strategy in identifying key market trends, shifts, and changes in paradigm for PPL's operations. Key tasks will include developing strategic roadmaps, long-range plans, and holistic solutions for complex problems within the organization. You will establish leading governance practices for key governance fora and develop collaterals for review meetings and external engagements. Serving as a liaison between ExCom members and other senior leaders will also be part of your responsibilities.,

DUTIES AND RESPONSIBILITIES Coordinates and supervises department operation. Stocking of nutrition products and other medications safely and properly and medicines are arranged from outside stores when it is required at emergency when the stock is not available in the in house pharmacy Overseeing organizational medicine list and medical use Review annually medication list for the patient safety and efficacy Procurement of medicines Selection of good quality product To receive the quotation from the different company for the better rates to the organization. As per doctor requirements to check the comparative rates Negotiation for scheme with supplier/manufacturer for the approved medicines Supervises departmental personnel including: hiring, orientation, determining workload and delegating assignments, training, monitoring, scheduling and evaluating performance, and initiative corrective and disciplinary actions. Prepares and dispenses medicines, chemicals and pharmaceutical preparations according to written orders by authorized medical practitioners with clinical privileges. Assist in selection, orientates, supervises, instructs departmental personnel. Initiates and implements Quality Improvement for the department. Preparing and assign duty and duty roster for the department staff Leading pharmacy committee Audit of medicines at nursing station for their expiry and storage condition Assisting assistant pharmacist in routine work whenever required Second check on gate pass Second check on the rates are properly supplied for the rate negotiated for the organization To forward the requisition for the medical head for making available of the new drug in the organization To inform to the prescriber for non availability of the drug in the pharmacy through a written notification and suggested for substitutions. To check the expiries are returned to the supplier credit note is received To check the invoices of the supplier are being forwarded for the payments To monitor the proper documentation for the narcotic drugs purchases sales and storage To Internalizing the S.O.P Physical stock taking of medicines quarterly