MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Post : Specialist External Quality
Job Description
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. With a diversified portfolio of prescription medicines, vaccines and animal health products, MSD's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Position Overview - Basic Functions & Responsibility Essential function(s) includes, but is not limited to: Ensures that all MSD products supplied by external manufacturers/partners (Contract Manufacturing Organizations and/or Alliances) 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 policy supporting the compliant supply of product by external manufacturers of API intermediates, API, non-sterile & sterile pharmaceuticals, biologics, drug delivery system and consumer care products, by means of a risk based quality oversight, support and technical advice, counselling of manufacturing site senior leadership and providing on-site supervision as appropriate.
Responsibilities include involvement or leadership in activities such as external manufacturer/partner selection and GMP Due Diligence, establishing of Quality Agreements between the companies; permanent audit readiness, providing coaching and training were applicable to build effective quality systems at the partner and supporting continuous improvement activities; support of product release where MSD holds the market authorizations, deviation investigations and change control requests. Assists in with market complaint investigations and market actions. The incumbent exercises a role in monitoring and maintaining the external manufacturers/partners compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign) and other pertinent legal requirements in accordance with Quality and Supply Agreement terms and Company Policy.
Primary Activities Primary activities include, :
Requires minimal support and oversight from the Associate Director and/or Director 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 total Quality Assurance program governing external manufacturers of API intermediates, API, non-sterile, sterile pharmaceuticals, biologics, drug delivery systems and consumer care products.
1. Assures compliance with established MSD policies/procedures and complies with all applicable governmental regulations (GMP, etc.), both domestic and foreign. Ensures that SOPs are prepared and maintained in compliance with regulatory standards, MSD requirements. Provides guidance to external manufacturer/partner with regards to MSD's requirements.
2. Assists or leads the development, and ongoing execution of the Quality Agreement with the external manufacturers/partners.
3. If necessary, conducts quality due diligence assessments of new external manufacturers/partners. Supports the partner in remediation of due diligence and/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.
4. Assists or leads coordination and communication on matters related to the cGMP status of the external manufacturer/partner. Must be conversant with all regulations and compendia (domestic and foreign) governing the external manufacturer’s operations. Works with the manufacturer/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.
5. May act as the MSD Quality point of contact for the external manufacturer and as a liaison between the external manufacturer and internal Merck personnel for activities including technology and method transfers, supplier Qualifications, equipment, processes and method validation, artwork, routine QA and QC activities such as change control/requests, batch records review and deviations investigation, quality complaints, and product release. 6. Responsibility of the incumbent may involve releasing of products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures of MSD and compliance with all governing regulations. Before shipment, he/she will assure that products manufactured by the external manufacturer/partner have the correct quality and identity, meet all pertinent specifications and special requirements, and have been produced by approved processes and under proper conditions. The incumbent will be trained and remain knowledgeable in the use of the appropriate release systems.
7. Assists or leads the responding to complaints from domestic and international markets.
8. Ensures that all deviations at external manufacturer/partners related to MSD Products are fully investigated with any assigned actions effectively implemented within the agreed time frame.
9. Assists the maintenance of retention samples, ships reagents and samples to support licensure and foreign registration.
10. Tracks and monitors operational and quality performance of the external manufacturer/partner.
11. May act as a regulatory compliance liason on Merck’s behalf to interface with regulatory agencies.
12. Provides proactive support in training and coaching to initiate quality improvements within Operations and Quality; reviews Annual Product Stability and Annual Product Reviews.
13. Monitors efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums.
14. In conjunction with other internal Merck departments (ACDS, GPC), ensures that external manufacturers 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.
15. Manages compliance issues promptly and performs risk assessments on critical issues to prevent stock out situation in the market.
16. Participates in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable.
17. Demonstrates and promotes EHS leadership behavior, ensuring that all MSD site activities are carried out in accordance with SHE requirements. 18. Ensures both operational knowledge and technical skills are maintained and compliant against individual training requirements
19. Assists or leads the coordination of significant investigations including Fact Findings. Assists in the coordination of any product recall involving the
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Candidate Profile
Degree in Science, Engineering or any relevant technical discipline (BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred). Must have strong demonstrated knowledge of applicable cGMP requirements. Knowledge of MSD Quality systems and broad experience in product Quality Assurance and Quality Control activities is expected. Must have strong interpersonal, relationship building and leadership skills; as well as good and effective communication, negotiation, and persuasion skills. Must be fluent in English, both spoken and written. Must be able to apply sound scientific principles, theories, concepts, techniques and skills. Demonstrates organizational skills, is proactive and self-motivated with ability to multi-task. Some level of contractual and financial awareness is preferred.
Additional Information:
Qualification: B.Sc, B.Pharm
Location: Mumbai
Last Date: 20th June, 2017
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