Opiniones MSD Salamanca

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Our Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Basic functions and responsibilities
Individual contributor responsible to ensure that all MSD products supplied by External Partners are manufactured, packaged, analyzed, released, stored and/or distributed in accordance with MSD expectations and all applicable regulatory requirements. Responsible for implementing Quality Assurance and Quality Control policies, supporting the compliant supply of product by External Partners, by means of a risk based quality oversight, support and technical advice and counselling to the partner.
Responsibilities include involvement in activities such as permanent audit readiness, providing coaching and training were applicable to build effective quality systems at the partner, and supporting continuous improvement activities. Support in product release where MSD holds the market authorizations, support in deviation investigations, complaint investigations and change control requests. Primary activities for the incumbent in this position are: Requires minimal support and oversight to complete responsibilities, including resolution of recurring/complex problems. Understands requirements for the role and has knowledge of assigned responsibility areas, including a combination of analytical/scientific skills in order to effectively manage and control activities necessary to support a Quality Assurance program governing External Partners that manufacture non sterile pharmaceuticals products.
Receives guidance and direction, but functions independently. Main responsibilities are: Assures compliance with established MSD policies/procedures and complies with all applicable governmental regulations (GMP, etc.) Provides guidance to External Partners with regards to MSD's requirements Assists the development, and ongoing execution of the Quality Agreement with the External Partners If necessary, assists in quality due diligence assessments of new External Partners. Supports the partner in remediation of due diligence or GMP audit gaps and ensures the audit observations related to MSD products are fully investigated with proposed actions and effectively, tracked and implemented within the agreed time frame where warranted Assists or leads coordination and communication on matters related to the cGMP status of the External Partner. Must be conversant with all regulations and compendia governing the external partner´s operations. Works with the partner to ensure that effective and robust Quality Systems are in place to comply with required regulations, policies and guidelines. Provides on-site guidance in the preparation of metrics, procedures and guidelines where warranted May act as the MSD Quality point of contact for the External Partner and as a liaison between the External Partner and internal MSD personnel for activities including technology and method transfers, supplier qualifications, equipment, processes and method validation, routine QA and QC activities Responsibility of the incumbent involve concurrent release of products with the assurance that the goods were produced in conformance to all applicable policies/procedures of MSD and compliance with all governing regulations Assists or leads the responding to complaints from market Ensures that all deviations at External Partners related to MSD Products are fully investigated with any assigned actions effectively implemented within the agreed time frame Tracks and monitors operational and quality performance of the External /Partner Provides proactive support in training and coaching to initiate quality improvements within Operations and Quality; reviews Annual Product Stability and Annual Product Reviews In conjunction with other internal MSD departments, ensures that external partners are inspection ready for all new product introductions or transfers, closely collaborating with appropriate business and operations areas, both internal and external, to achieve MSD objectives Manages compliance issues promptly and performs risk assessments on critical issues to prevent stock out situation in the market Participates in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable Demonstrates and promotes EHS leadership behavior, ensuring that all MSD site activities are carried out in accordance with SHE requirements Ensures both operational knowledge and technical skills are maintained and compliant against individual training requirements Assists the coordination of significant investigations including Fact Findings. Assists in the coordination of any product recall involving the external partner Qualifications BS Pharmacy, Chemistry, Chemical Engineering, Biology (or equivalent), preferred. Minimum of three years experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements. Must be fluent in English, both spoken and written. Competent in scientific problem solving and risk analysis capabilities. Strong compliance mindset, demonstrated interpersonal skills,as well as communication and negotiation skills. Demonstrates organizational skills, is proactive and self-motivated with ability to multi-task. Some level of contractual and financial awareness is preferred.
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.
MSD is not accepting unsolicited assistance from search firms / recruitment agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD. No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.

Job: Qual Assurce - 3rd Party Manuf

Primary Location: EMEA-Spain-M-Madrid

Other Locations: EMEA-Belgium-Antwerp-Heist op den Berg, EMEA-Portugal-Lisbon-Lisbon, EMEA-Netherlands-NH-Haarlem, EMEA-United Kingdom-ENG-Cramlington, EMEA-United Kingdom-ENG-London, Europe, Middle East & Africa, EMEA-Russia-Moscow-Moscow, EMEA-France-V-Ardèche, EMEA-Italy-Lazio-Rome, EMEA-Turkey-Istanbul-Istanbul

Employee Status: Regular

Travel: Yes, 25 % of the Time

Number of Openings: 1

Company Trade Name:MSD