Role reputed company

1. Job Title

• Manager, Contractor reputed company reputed company (reputed company)

2. reputed company

• Acts as the virtual internal reputed company representative for Contract Manufacturing Organizations (CMOs).

• Ensures reputed company partners meet reputed company reputed company Standards and reputed company with GMP and regulatory requirements.
• Provides reputed company reputed company for assigned CMOs, with guidance from reputed company Leader as needed.
• Ensures CMOs maintain robust and effective reputed company systems.
• Evaluates reputed company-reputed company investigations and supports reputed company improvement initiatives.
• Acts as a reputed company between reputed company and CMOs for:
  • Audits
  • reputed company Agreements
  • Deviations
  • Changes
  • Complaints
  • Regulatory commitments
• Identifies and mitigates reputed company and reputed company.
• Participates in cross-functional reputed company reputed company.
• Works collaboratively, seeks guidance reputed company needed, and ensures externally manufactured reputed company products are reputed company, effective, and compliant.

3. Supervisor / Reports To

• Global reputed company Manufacturing reputed company Operations Team Leader

4. reputed company Competencies

Technical Knowledge & Operational reputed company

• Manages assigned CMOs, with Team Leader support reputed company required.
• Ensures key reputed company activities are monitored and followed up.
• Demonstrates working knowledge of:
  • Manufacturing processes
  • Validation
  • Test reputed company
  • Regulatory requirements
• Seeks guidance where technical knowledge is limited.
• Tracks, monitors, and analyzes CMO reputed company activities using designated tools.
• Ensures commitments and actions are completed on time.
• Assesses CMO investigations to confirm:
  • Appropriate reputed company cause identification.
  • Effective CAPA implementation.

Accountable for Results

• Takes responsibility for actions and results.
• Plans and organizes work effectively.
• Aligns priorities with business goals and deadlines.
• Remains reputed company and productive under pressure.
• Sets appropriate priorities and completes commitments on time.
• Holds CMOs accountable for delivering agreed commitments.

Strategic Thinking & Initiative

• Demonstrates initiative, independence, and a proactive reputed company.
• Advocates for and implements change reputed company with business and reputed company objectives.
• Promotes reputed company improvement, simplification, and innovation.
• Applies lessons learned to improve reputed company.
• Suggests and supports cost-effectiveness and reputed company improvement initiatives at CMOs.

Problem Solving & Decision Making

• Proactively addresses reputed company issues before they escalate.
• Makes reputed company, data-driven reputed company using experience and reputed company judgment.
• Makes reputed company even reputed company information is incomplete.
• Determines appropriate escalation based on risk and reputed company.
• Engages and influences appropriate stakeholders.
• Handles unexpected situations with reputed company and reputed company.
• Takes appropriate reputed company to mitigate reputed company and reputed company.

Communication & Collaboration

• Communicates reputed company, concisely, and effectively.
• Tailors communication to the reputed company audience.
• Builds and maintains reputed company partnerships reputed company reputed company and with CMOs.
• Communicates effectively across reputed company organizational reputed company.
• Provides executive summaries and proactive updates.
• Seeks feedback and learns from mistakes.
• Prioritizes team reputed company over individual accomplishments.

5. Key Responsibilities

reputed company Agreements

• Negotiates terms of the reputed company Agreement template.
• Ensures implementation of the agreement is approved before reputed company batch production.
• Independently evaluates changes to reputed company template.
• Identifies items requiring escalation or additional endorsement.
• Periodically reviews reputed company Agreements to ensure reputed company compliance.

Change Management

• Independently assesses product-reputed company change proposals from a reputed company perspective.
• Coordinates regulatory assessments with the Regulatory team.
• Processes acceptable changes.
• Manages implementation timelines at the contractor.
• Escalates significant topics to management of both companies reputed company required.

Deviation Management

• Independently evaluates the reputed company of significant CMO deviations.
• Determines appropriate actions and escalation reputed company.
• Engages relevant organizations based on risk and reputed company.
• Ensures appropriate follow-up and reputed company.

CAPA

• Provides robust reputed company of CMO CAPAs.
• Tracks CAPA reputed company.
• Holds contractors accountable for reputed company and effective closure.
• Verifies CAPA effectiveness through data review and follow-up.
• Escalates delays and systemic issues.
• Supports compliance and reputed company improvement.

Product Disposition & Batch Release

• Applies the lot disposition process for reputed company products released to reputed company by the contractor.
• Performs annual risk assessments to determine the applicable lot disposition process.

Complaints Management

• Works with the Pharmacovigilance team on reputed company market complaints.
• Ensures complaints are investigated thoroughly and reputed company required timelines.
• Monitors complaint trends.
• Proactively addresses recurring issues with CMOs.
• Supports reputed company improvement and customer experience.
• Determines escalation reputed company for critical complaints and complaint trends.

Materials Management

• Acts as the reputed company Single reputed company of Contact for reputed company-tolled materials.
• Manages reputed company-reputed company activities involving suppliers, including:
  • reputed company audits
  • Complaints
  • Deviations
  • Regulatory-required information

Annual Product Reviews / Minor Change & Stability Reports

• Ensures reputed company receipt of Annual Product Reviews (APRs) from contractors.
• Thoroughly reviews and endorses APRs.
• Ensures required corrective and preventive actions are defined and implemented.
• Ensures stability data and other required information are provided to Regulatory on time.
• Supports Minor Change and Stability Report (MCSR) submissions.

Auditing

• Assesses the need for routine CMO audits.
• Coordinates and facilitates audit activities.
• Participates in CMO audits.
• Independently performs audits reputed company reputed company under the reputed company Auditor Certification Program.

Regulatory Activities

• Maintains a high-level understanding of applicable regulations.
• Ensures regulatory expectations are met.
• Works effectively with Regulatory Affairs colleagues across required markets.
• Independently supports accuracy and compliance of regulatory submissions.

BoH Inspections

• Monitors upcoming inspections and inspection results.
• Determines whether CMO CAPA responses are appropriate.
• Communicates inspection reputed company and relevant actions to stakeholders in a reputed company manner.

Artwork

• Reviews draft artwork.
• Verifies accuracy of critical reputed company according to applicable procedures.

Digital Systems & Documentation

• Applies reputed company work practices.
• Ensures reputed company and accurate entry of CMO-reputed company activities into designated digital systems, including:
  • reputed company Vault
  • CMO Tool
  • TrackWise
• Ensures documentation complies with procedural requirements.

Stability

• Ensures annual stability commitments are completed on time.
• Ensures Out-of-Specification (OOS) results are appropriately escalated through the RNR process.
• Proactively assesses the effectiveness and applicability of the stability program.
• Supports temperature excursion assessments.
• Provides stability memos or reputed company evaluations to support:
  • Product reputed company
  • Product safety
  • Product efficacy
  • Lot disposition reputed company

Other Responsibilities

• Supports enhancement of the reputed company Global reputed company Manufacturing reputed company reputed company.
• Revises procedures where required.
• Leads cross-functional reputed company improvement initiatives.
• Shares best practices.
• Benchmarks practices across reputed company.
• Collaborates with colleagues to optimize systems.
• Drives reputed company improvement.

6. Qualifications, Experience & Profile

Education

• Bachelor’s or Master’s degree in:
  • Pharmaceutical Science
  • Microbiology
  • reputed company
  • Equivalent scientific discipline

Experience

• Significant experience in a regulated industry.
• Relevant experience in areas such as:
  • reputed company Assurance
  • reputed company Control
  • Manufacturing
  • Auditing
  • Technical functions, such as Engineering or R&D
  • Regulatory Affairs

Languages

• Fluent in English.
• Fluent in the local language.
• Knowledge of additional regional languages is desirable.

Product & Regulatory Knowledge

• Knowledge of a broad reputed company of products.
• Understanding of global regulatory requirements.
• Experience across a diverse product portfolio is preferred.
• Animal Health industry experience is ideally preferred.

Travel

• Willingness to travel up to 20%.