11 Oct

Manager Quality Validation Jobs Vacancy in Coherus Biosciences San Francisco

Manager Quality Validation
Coherus Biosciences
San Francisco CA
11 Oct, 2018 30+ days ago

Coherus Biosciences San Francisco urgently required following position for Manager Quality Validation. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.

Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.

Manager Quality Validation Jobs Vacancy in Coherus Biosciences San Francisco Jobs Details:

The Quality Validation Manager will be responsible to ensure all commercial quality and technical activities, including validation are performed in compliance with corporate and regulatory requirements. This role covers manufacturing process, packaging, and computer system validation both internally and externally across the CMO / CPO network.

Principle Responsibilities and Duties:

  • Review and approve Validation documents, plans, protocols, and reports used in support of activities (internal and external) to ensure compliance (e.g. 21 CFR Part 210-211)
  • Administer and maintain risk based, quality driven procedures and practices with respect to engineering and qualification validation. Develop and enhance validation programs to reflect current, best practice regulatory expectations and support the business model and objectives for Coherus.
  • Serve as the technical expert for Quality, provide guidance and review of external validation activities to ensure that CMOs are meeting Coherus standards/expectations in support of Coherus product pipeline.
  • Support the change control program with respect to facility, equipment, and cleaning validation changes. Support the Information Technology change control program for computerized systems. Evaluate validation impact of manufacturing process changes, equipment upgrades, deviations and product nonconformance events.
  • Support the investigations program with respect to engineering, qualification, and cleaning validation related investigations, including trending and corrective and/or preventative actions.
  • Attend onsite visits to contractors and where needed, equipment manufacturers to support validation activities.
  • Establishes Validation Program, inclusive of Validation Master Plans and standards for Validation Documentation, plus corollary SOPs. Provide training/guidance to Quality and Manufacturing personnel on relevant policies and SOPs.
  • Assist in the identification, development, and implementation of new technologies to meet best practice expectations in the Manufacturing and Laboratory environments. Provide technical support for system owners and administrators for various facility systems, manufacturing equipment, and laboratory instruments.
  • Ensure timely, efficient and effective communication and/or interaction with regulatory agencies, internal GxP partners, external contract providers or external contracting organizations. Provide timely and effective completion of relevant activities in support of regulatory filings, production schedules and/or customer needs with respect to facilities, equipment and computer system validation.
Experience, Education, Training, Traits:
  • Minimum of a Bachelor's degree (or equivalent) in scientific related field and 10 years of experience required. Minimum of 5 years qualification and validation experience strongly preferred.
  • Detailed knowledge of Aseptic Manufacturing, working knowledge of Pharmaceuticals GxPs (21 CFR Part 210-211) and/or Device GMPs (21 CFR Part 820), EU GMPs (Annex 1) and the ability to assess compliance risks.
  • Knowledge of System Development Life Cycle concepts and software (GAMP5 expected pharmaceutical standards, 21 CFR Part 11, Annex 11).
  • Must have strong leadership and management skills with experience forming and leading high performance teams.
  • Must possess excellent organizational and deductive reasoning skills. Strong communication and written skills are required. Working knowledge of MasterControl and Microsoft Office, including Word and Excel is preferred. Must demonstrate the ability to multi task by performing multiple projects and tasks simultaneously. Must be able to work and interact well with other employees at all levels.
  • Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments.

Jobs Vacancy Related to Manager Quality Validation:


Automation Engineering Manager Jobs Vacancy in Retail Solutions Inc San Jose. Retail Solutions Inc San Jose opening great career opportunity and jobs vacancy for Automation Engineering Manager position. This jobs vacancy will be open for new jobs applicant starting for 30 Dec, 2018. Participate in and contribute to the completion of sprints by driving the quality assurance process and product validation, testing both manually and with... ... Continue reading -->


Manager Quality Control Lab Jobs Vacancy in Johnson Family Companies Lititz. Johnson Family Companies Lititz opening great career opportunity and jobs vacancy for Manager Quality Control Lab position. This jobs vacancy will be open for new jobs applicant starting for 01 Oct, 2018. The Manager Quality Control Lab will be responsible for managing and coordinating the activities of the Quality Control associates engaged in sorting, testing,... ... Continue reading -->


Manager Quality Assurance Continuous Improvement Jobs Vacancy in Brown Forman Louisville. Brown Forman Louisville opening great career opportunity and jobs vacancy for Manager Quality Assurance Continuous Improvement position. This jobs vacancy will be open for new jobs applicant starting for 16 Jan, 2019. Establish quality goals with production site Quality Control Manager and General Manager each year. Relevant professional certifications in quality such as ASQ... ... Continue reading -->


Senior Quality Assurance Specialist Lead Jobs Vacancy in Bmo Financial Group Naperville. Bmo Financial Group Naperville opening great career opportunity and jobs vacancy for Senior Quality Assurance Specialist Lead position. This jobs vacancy will be open for new jobs applicant starting for 21 Dec, 2018. Ability to translate technical terms based on different audiences, e.g. executives, managers, working teams.... ... Continue reading -->


Manager Validation Jobs Vacancy in Thermo Fisher Scientific St. Louis. Thermo Fisher Scientific St. Louis opening great career opportunity and jobs vacancy for Manager Validation position. This jobs vacancy will be open for new jobs applicant starting for 12 Dec, 2018. The Validation Manager will have responsibility over the validation maintenance program at the St. The Manager ensures the validation program is in compliance... ... Continue reading -->