Qureos Mentor

Getz Pharma

<div>
 
 
 Job Responsibilities:
 
 
 <ul>
 <li>
 Initiate, assess, and manage change controls related to facilities, equipment, materials, processes, documents, and systems.
 </li>
 <li>
 Ensure proper risk assessment, impact analysis, and timely closure of change controls in compliance with ICH Q10 and WHO guidelines.
 </li>
 <li>
 Liaise with cross-functional departments to evaluate proposed changes and ensure adequate controls are in place.
 </li>
 <li>
 Oversee the logging, classification, and evaluation of deviations from approved processes and procedures.
 </li>
 <li>
 Lead cross-functional teams in conducting thorough
 
 root cause analysis (RCA)
 
 using scientific tools and methodologies.
 </li>
 <li>
 Ensure deviations are investigated, documented, and closed within defined timelines, with appropriate corrective and preventive actions.
 </li>
 <li>
 Ensure CAPAs are properly identified, implemented, tracked, and verified for effectiveness.
 </li>
 <li>
 Monitor trends in deviations, complaints, and audit findings to proactively identify areas for improvement.
 </li>
 <li>
 Facilitate CAPA boards or review meetings and maintain compliance with ICH Q10 principles of pharmaceutical quality systems.
 </li>
 <li>
 Apply systematic problem-solving tools such as
 
 5 Whys
 
 ,
 
 Ishikawa diagrams
 
 , etc. to identify true root causes.
 </li>
 <li>
 Train and mentor staff in effective RCA practices to strengthen the culture of quality and compliance.
 </li>
 <li>
 Conduct and review risk assessments (as per ICH Q9) to support decision-making for deviations, changes, and CAPAs.
 </li>
 <li>
 Implement risk mitigation strategies and monitor effectiveness over time.
 </li>
 <li>
 Support development and periodic review of risk management plans for critical processes and systems.
 </li>
 <li>
 Review completed batch manufacturing records (BMRs), quality control results, and associated documentation for compliance.
 </li>
 <li>
 Ensure that only conforming products are released, and that batch release meets applicable regulatory and internal quality standards.
 </li>
 <li>
 Ensure adherence to
 
 Good Documentation Practices (GDP)
 
 and review of SOPs, protocols, and reports.
 </li>
 <li>
 Support document control activities and ensure that controlled documents are maintained, revised, and distributed appropriately.
 </li>
 <li>
 Participate in data integrity initiatives and ensure records are attributable, legible, contemporaneous, original, and accurate (ALCOA+).
 </li>
 <li>
 Prepare and present QMS-related data and documents during internal audits and external inspections.
 </li>
 <li>
 Assist in timely closure of audit findings and implementation of sustainable improvements.
 </li>
 <li>
 Promote a culture of continuous improvement within the QA-QMS team.
 </li>
 <li>
 Identify trends and systemic issues using QMS metrics and propose preventive strategies.
 </li>
 <li>
 Conduct QMS training for site personnel to enhance compliance awareness.
 </li>
 </ul>
 
 
 
 Required Experience, Knowledge &amp; Skills
 
 
 
 <ul>
 <li>
 Master&rsquo;s degree in Chemistry, Applied Chemistry, Pharmaceutical Sciences (Pharm-D), or a related field.
 </li>
 <li>
 6-8 years of experience in Quality Assurance &amp; Compliance in a pharmaceutical manufacturing environment.
 </li>
 <li>
 In-depth knowledge of WHO GMP, ICH Q8, Q9, Q10, and other applicable global regulatory standards.
 </li>
 <li>
 Strong working knowledge of investigation techniques, CAPA effectiveness checks, and compliance management.
 </li>
 <li>
 Hands-on experience with QMS software tools and electronic documentation systems is preferred.
 </li>
 <li>
 Excellent analytical, communication, and documentation skills.
 </li>
 <li>
 Ability to work independently and collaboratively in a fast-paced environment.
 </li>
 <li>
 Detail-oriented with a strong compliance and continuous improvement mindset.
 </li>
 </ul>
 
 
</div>

Assistant Manager QA-QMS

<div>
 
 
 
 Position Summary:
 
 
 
 
 Drive pipeline planning &amp; development activities to consistently replenish Getz Pharma&rsquo;s generic and biosimilar pipeline with new products in Pakistan and International markets, targeting early access for patients. Perform &amp; execute the ideation, lead generation, holistic evaluation and other project management activities for introduction &amp; induction of new products &amp; therapies, new segments, new facilities/technologies and business partnerships.
 
 
 
 
 
 
 
 Requirements:
 
 
 
 <ul>
 <li>
 PharmD/MBBS, MBA preferable but not mandatory
 </li>
 <li>
 Candidate should have a strong business as well as scientific acumen
 </li>
 <li>
 Should possess a flair for Pharmacology
 </li>
 <li>
 Innovative professional with interest in novel therapies
 </li>
 <li>
 4-6 yrs of overall experience with current experience in Business development function of reputed pharmaceutical industry is desirable. Prior work experience in Medical Affairs function of pharma industry or a large tertiary care hospital will be encouraged.
 </li>
 </ul>
</div>

Assistant Manager Business Development

Join Getz Pharma and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Getz Pharma

ABOUT_COMPANY

Assistant Manager QA-QMS

Assistant Manager Business Development