Quality Operation is responsible to support the entire Couvet site to ensure that each GxP-stakeholder operates in compliance with the site's Quality Management Systems (QMS), the cGMP and the applicable laws, regulations, and standards; and support client relationships by ensuring that TMA quality agreement is respected.

The position holder is responsible to ensure the proper support of the GxP stakeholder, the proper application and use of the QMS, the proper control of all the GxP processes and the investigation and assessment of any issue, to review and approve master and executed batch records.

As a member of the Quality Leadership Team, the position holder is collaborating with the other members of the QLT to ensure that on the Couvet site the Quality Systems are maintained and improved, and that any cGxP compliance issue is duly addressed in a timely manner.

• At least 7 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry.
• Bachelor’s degree in pharmacy, Chemistry, Microbiology, or related science.

• Knowledge / Skills / Abilities:

  • Thorough understanding of cGMPs and EU, Swiss, and FDA regulatory requirements.
  • Solid understanding of Oral Solid Dosage form manufacturing, packaging, testing, warehousing processes, and validation.
  • Strategic thinking, business acumen, holistic approach, leading vision, innovation management, and negotiation. Ability to transfer strategies to tactical execution.
  • Excellent interpersonal, collaborative, and organizational skills.
  • Strong communication skills. Ability to communicate effectively to management, functional groups, broader organization, and executives.
  • High credibility and reliability.
  • Excellent investigational and QA problem solving skills.
  • Ability to interpret complex situations with degree of independence and to articulate recommendations for resolution.
  • Drives continuous improvement.
  • Knowledge of most common office software and of IT principles.

  Leadership Activities: (only for people manager roles)

  • Responsible for supervision/training of Operators (Junior, Senior, Lead) — previous supervisory experience not required, but is a plus.
  • Must be able to work unsupervised, and along with operators/engineers.
  • Must be able to organize and lead training sessions on new equipment or procedures.

  An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability

  This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

   

   

• Act as the deputy of the Responsible Person (RP) according to Art. 5, and Art. 17 of the Swiss Ordinance on Establishment Licenses (SR 812.212.1) and of the Qualified Person according to Annex 16 of the EU Guide to Good Manufacturing Practice for Couvet site.
• Builds and leads a team assured that adequate staff, organization, equipment and facilities are available to complete the assigned tasks.
• Assigns tasks to direct reports in accordance with their responsibilities and capabilities. Ensures continuous professional development and guidance to direct reports.
• Responsible for resolution of process and protocol deviations, assuring effective root cause identification and corrective/preventive actions to of any deficiencies identified during manufacturing, packaging, audits (corporate, regulatory, client or internal), testing (including OOx reports), batch record reviews.
• Works closely together with the Bulk, Packaging, Warehouse, Manufacturing Technical Services, QC Laboratory, MS&T, and AS&T management to improve systems and processes, to transfer new products and analytical method, and to solve any problems, providing GxP and analytical trouble­shooting support.
• Ensures compliance to the policy of security at work and to laws concerning health and security of the workers within the area of responsibility.
• Works closely with EHS to evaluate hazards and perform risk analysis
• Promotes safe practices and behaviors, verify that EHS rules are implemented

Deputy role for and deputy activities

The position acts as deputy of the Site RP for the following quality processes activities under his/her responsibility.

• Release of batches as RP deputy
• Close out of Critical Complaints.
• Approval of Complaints Extension Requests when an escalated approval is required.
• Approval of Investigation Reports/Notifications sent to Health Authorities related to Complaints.
• Approval of documentation related to Suppliers/CSPs qualification and maintenance activities.
• APR/PQR approval