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GVK Bio-general Manager-qa for Formulation & Analytical Services (fas)

15 - 20 YearsHyderabad

Not Disclosed by RecruiterOpenings: 1Posted: 35 days agoJob Applicants: 517Job Views: 1415
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Job Description

Responsibilities:

Ensuring right ecosystem for Quality function
:
  • Contribute to developing quality goals and targets in the organizations strategic plan
  • Evaluate results of quality operations; prepare recommendations regarding significant changes that need to be made to the organizations manufacturing processes, system, technology, raw materials, inputs , vendor, etc
  • Liaise with functional and operations managers (R&D, Manufacturing, Engineering, SCM, HR, Administration, etc) for implementing new procedures, processes or methods to improve quality and performance.
  • Guide team to meet regulatory requirements in accordance to respective country/regions guidelines by designing, developing and implementing quality standards.
  • Effective use of operating budgets; ensure effectiveness of quality operations

Ensuring effective operations of Quality department by effectively managing teams to:


  • Monitor that quality targets and standards are met in the organization.
  • Ensure implementation of Quality Risk Management system
  • Liaise with external customers and regulatory authorities for effective implementation of quality and regulatory systems.
  • Ensure adequacy & sufficiency of data for faster regulatory approvals
  • Plan and prepare regulatory submissions for bulk actives
  • Making sure that deviations are investigated and resolved.
  • Reviewing and approving validation protocols and reports.
  • Making sure that effective systems are used for maintaining and calibrating critical equipment.
  • Making sure that materials are appropriately tested and the results are reported.
  • Performing product quality reviews.
  • Develop the team as quality experts who ensure quality management system implementation in letter & spirit


Investigation activities:
  • Ensure that quality related complaints/ deviations are investigated and resolved.
  • Close investigation issues with appropriate Corrective Action & Preventive Action (CAPA)
  • Assess, review and provide inputs towards root-cause analysis
  • Guide team to build investigative skills

Handling of Audits:
  • Ensure internal audits are carried out as per schedule and necessary corrective active preventive action is taken.
  • Host regulatory audits and provide response to queries
  • Develop / train the team to interact/ face regulatory and client audits and demonstrate the GMP adherence
  • Ensure anytime audit readiness
Ensure Good Documentation Practices (GDPs):
  • Accurate & up-to-date technical documents in accordance with regulatory compliance
  • Archival & retrieval of documents
  • Prepare / review documents / reports as maybe required
  • Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Optimum utilization of resources:

  • Plan for optimum utilization of resources (manpower, materials and infrastructure) for deliverables

Maintain records, data integrity & safety:
  • Maintain strict data integrity and adhere to all related policies
Understand & adhere to safety norms

  • Ensure skill development of self & team:
  • Inspire, motivate, hire, and retain right talent
  • Participate in recruitment process
  • Motivate, recognize and retain best talent through various reward & recognition programs
  • Train and develop team members through Learning & Development programs
  • Enhance team performance through periodic reviews and corrective measures
  • Career management discussions with team members
  • Mentor team members
  • Improve employee satisfaction scores
  • Continuously update self on industry trends
Ideal Background

Education (minimum/desirable): M.Sc./M. Pharm. - Chemistry (Organic/Analytical) with Certified Lead Auditor and 15 - 20 yrs relevant experience
Desirable: PhD or equivalent.

Experience/Professional requirement: 1. Knowledge of and compliance with regulatory guidelines
2. Knowledge of quality management systems & data investigative techniques
3. Ability to prepare, review and communicate tech-nical documents
4. Knowledge of and adherence to GxP guidelines
5. Data integrity, safety & continual Improvement
6. Knowledge of Analytical Method Validation and Development
7. Good Communication skills



Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: R&D
Role: Bio/Pharma Informatics-Associate/Scientist
Employment Type: Permanent Job, Full Time
Keyskills:

Company Profile

GVK Biosciences Pvt. Ltd.
GVK is today among India’s leading transnational business conglomerates. GVK’s areas of activity range from power and hospitality to biotechnology, manufacturing, finance, petrochemicals and infrastructure development. The diverse GVK enterprises are united by a common vision. GVK is dedicated to making positive contributions for a better future.
View Contact Details+
Contact Details

Recruiter Name:Karthik PV

Contact Company:GVK Biosciences Pvt. Ltd.

Email :karthik.palaparthi@gvkbio.com

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