QA Manager Npi

vor 2 Wochen

Couvet, Schweiz WuXi AppTec Inc Vollzeit

Overview:
QA NPI is responsible for supporting the entire Couvet site to ensure that each new product is manufactured, packaged, and tested in compliance with the GMP and according Product Owner.

**Responsibilities**:

- Act within the site's new product introduction projects teams as the main Quality Operations representative and single point of contact for QA, QC, Compliance, Quality Supplier.
- Coordinate and drive quality activities related to:

- Technology tech transfer,
- Analytical tech transfer,
- Raw materials introduction,
- Manufacturing specifications,
- CMC dossier set up.
- Conduct assessment of change controls for new product related projects.
- Contact with the client regarding quality topics
- Coordinates response / notification to the client related to quality topics, Coordinates response related to regulatory authorities requests, e.g. in the scope of submission or periodic GMP review.
- Actively support site Quality activities such as:

- multi sites investigations, drive change controls upon requests,
- client notification
- health authority inspections
- continuous improvement
- 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 and followed

**Deputy role for and deputy regulatory compliance activities**

The position acts as deputy of the regulatory compliance manager

Qualifications:
**Experience / Education**

French and English fluent
- At least 7 years of experience in Quality Assurance, Quality Control, and/or Regulatory Affair 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 Swiss, EU, and FDA regulatory requirements.
- Demonstrated experience in Regulatory strategies and tactics.
- Strong knowledge of all phases from the global drug development process and clinical trial data flow up to analytical/technology transfer to manufacturing/testing site and product launches.
- Solid understanding of Oral Solid Dosage form manufacturing, packaging, testing, warehousing processes, validation, and registration.
- 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.

**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 on the basis of 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.

  • QA Operations Coordinator

    vor 2 Wochen

    Couvet, Schweiz WuXi AppTec Vollzeit

    Join our QA Operations Team dedicated to supporting the Couvet site and various departments in ensuring compliance with cGMP processes and products!This role involves hands-on support for QA Operations activities on the floor, such as archiving, addressing complaints, and document revisions. You may also take on additional tasks like managing quality metrics...

  • Associate Specialist QA Operations

    vor 2 Wochen

    Couvet, Schweiz WuXi AppTec Vollzeit

    QA Operations Team is dedicated to actively supporting the Couvet site and other departments to ensure compliance with cGMP processes and products.This role involves quality assurance (QA) primarily focused on reviewing bulk or packaged commercial drug products, raw material batches if necessary, and maintaining relationships with QA departments at contract...

  • Engineer, Manufacturing

    vor 1 Woche

    Couvet, Schweiz STA Pharmaceutical Switzerland SA Vollzeit

    ResponsibilitiesThe Manufacturing Engineer's main activities are completed autonomously for the following tasks and responsibilities: Author and review manufacturing (bulk/packaging) documents, including specifications, working practices, transfer protocol, master batch record, Forms and logbooks. Follow up approval flow within electronic documentations...

  • Engineer, Manufacturing

    vor 4 Wochen

    Couvet, Schweiz STA Pharmaceutical Switzerland SA Vollzeit

    The Engineer, Manufacturing is involved in the new product introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. He/she is involved in all the technical activities related to manufacturing. He/she authors, owns and leads updates of GMP documents related to new product introduction for Bulk and/or Packaging Operations. He/she...

  • Engineer, Manufacturing

    vor 2 Wochen

    Couvet, Neuenburg, Schweiz WuXi AppTec Vollzeit

    The Engineer, Manufacturing is involved in the new product introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. He/she is involved in all the technical activities related to manufacturing. He/she authors, owns and leads updates of GMP documents related to new product introduction for Bulk and/or Packaging Operations. He/she...

  • Engineer, Manufacturing

    Vor 2 Tagen

    Couvet, Schweiz STA Pharmaceutical Switzerland SA Vollzeit

    #slim #content {border: none;margin: 0;padding: 0;} #slim .slim_picture {text-align: left;margin: 0 10px 20px 0;} #slim .slim_picture img {max-height: 126px;} #slim .slim_content {border: none;} #slim .slim_title {font-size: 24px;font-weight: bold;margin: 0 0 10px 0;text-align: left;line-height: 32px;word-wrap: break-word;} #slim .slim_text {padding: 0...

  • Engineer, Manufacturing

    vor 4 Wochen

    2108 Couvet, Schweiz WuXi AppTec Vollzeit

    The Engineer, Manufacturing is involved in the new product introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. He/she is involved in all the technical activities related to manufacturing. He/she authors, owns and leads updates of GMP documents related to new product introduction for Bulk and/or Packaging Operations. He/she...

  • Engineer, Manufacturing

    vor 4 Wochen

    2108 Couvet, Schweiz WuXi AppTec Vollzeit

    The Engineer, Manufacturing is involved in the new product introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. He/she is involved in all the technical activities related to manufacturing. He/she authors, owns and leads updates of GMP documents related to new product introduction for Bulk and/or Packaging Operations. He/she...

  • Engineer, Manufacturing

    vor 3 Wochen

    2108 Couvet, Schweiz WuXi AppTec Vollzeit

    The Engineer, Manufacturing is involved in the new product introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. He/she is involved in all the technical activities related to manufacturing. He/she authors, owns and leads updates of GMP documents related to new product introduction for Bulk and/or Packaging Operations. He/she...

  • Engineer, Manufacturing

    vor 4 Wochen

    2108 Couvet, Schweiz WuXi AppTec Vollzeit

    The Engineer, Manufacturing is involved in the new product introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. He/she is involved in all the technical activities related to manufacturing. He/she authors, owns and leads updates of GMP documents related to new product introduction for Bulk and/or Packaging Operations. He/she...

  • Engineer, Manufacturing.

    vor 3 Wochen

    Couvet, Val-de-Travers, NE, Schweiz WuXi AppTec Vollzeit

    The Engineer, Manufacturing is involved in the new product introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. He/she is involved in all the technical activities related to manufacturing. He/she authors, owns and leads updates of GMP documents related to new product introduction for Bulk and/or Packaging Operations. He/she...

  • Engineer, Manufacturing.

    vor 3 Wochen

    Couvet, Val-de-Travers, NE, Schweiz WuXi AppTec Vollzeit

    The Engineer, Manufacturing is involved in the new product introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. He/she is involved in all the technical activities related to manufacturing. He/she authors, owns and leads updates of GMP documents related to new product introduction for Bulk and/or Packaging Operations. He/she...

  • Manager Bulk Operations Manufacturing

    Vor 7 Tagen

    Couvet, Schweiz Wapt Vollzeit

    Overview: This position is a leadership role being responsible in direct management of individual contributors and/or supervisors and/or managers. This position is a safeguard and role model for the WuXi values and competencies. **Job Summary**: Lead the bulk operations and ensure that packaging goods are produced according to supply needs and as per the...

  • Manager Bulk Operations Manufacturing

    vor 4 Wochen

    Couvet, Schweiz STA Pharmaceutical Vollzeit

    Overview: This position is a leadership role being responsible in direct management of individual contributors and/or supervisors and/or managers. This position is a safeguard and role model for the WuXi values and competencies. **Job Summary**: Lead the bulk operations and ensure that packaging goods are produced according to supply needs and as per the...

  • Manager Bulk Operations Manufacturing

    Vor 3 Tagen

    Couvet, Schweiz STA Pharmaceutical Switzerland SA Vollzeit

    #slim #content {border: none;margin: 0;padding: 0;} #slim .slim_picture {text-align: left;margin: 0 10px 20px 0;} #slim .slim_picture img {max-height: 126px;} #slim .slim_content {border: none;} #slim .slim_title {font-size: 24px;font-weight: bold;margin: 0 0 10px 0;text-align: left;line-height: 32px;word-wrap: break-word;} #slim .slim_text {padding: 0...

  • Manager Bulk Operations Manufacturing

    vor 2 Wochen

    Couvet, Schweiz WuXi AppTec Vollzeit

    This position is a leadership role being responsible in direct management of individual contributors and/or supervisors and/or managers. This position is a safeguard and role model for the WuXi values and competencies. Job Summary: Lead the bulk operations and ensure that packaging goods are produced according to supply needs and as per the highest...

  • Manager Bulk Operations Manufacturing

    vor 2 Wochen

    Couvet, Neuenburg, Schweiz STA Pharmaceutical Vollzeit

    Overview:This position is a leadership role being responsible in direct management of individual contributors and/or supervisors and/or managers.This position is a safeguard and role model for the WuXi values and competencies.Job Summary:Lead the bulk operations and ensure that packaging goods are produced according to supply needs and as per the highest...

  • Manager Bulk Operations Manufacturing

    vor 1 Woche

    Couvet, Schweiz STA Pharmaceutical Switzerland SA Vollzeit

    OverviewThis position is a leadership role being responsible in direct management of individual contributors and/or supervisors and/or managers.This position is a safeguard and role model for the WuXi values and competencies. Job Summary:Lead the bulk operations and ensure that packaging goods are produced according to supply needs and as per the highest...

  • Specialist, Manufacturing Compliance

    vor 4 Wochen

    2108 Couvet, Schweiz WuXi AppTec Vollzeit

    The Engineer, Manufacturing Compliance authors, owns and leads updates of GMP documents related to Bulk and/or Packaging Operations. He/she initiates and owns deviations related to Bulk and/or Packaging Operations and leads investigation tasks as required. He/she supports the Head of Bulk and/ or Packaging Operations in monitoring quality and performance...

  • Specialist, Manufacturing Compliance

    vor 4 Wochen

    2108 Couvet, Schweiz WuXi AppTec Vollzeit

    The Engineer, Manufacturing Compliance authors, owns and leads updates of GMP documents related to Bulk and/or Packaging Operations. He/she initiates and owns deviations related to Bulk and/or Packaging Operations and leads investigation tasks as required. He/she supports the Head of Bulk and/ or Packaging Operations in monitoring quality and performance...