Assistant Manager - COMPLIANCE AND TECHNICAL SERVICES

Felix Pharmaceuticals Pvt. Ltd.; Varanasi; Vor Ort; INR 1.200.000 - 1.800.000; Vollzeit

Zusammenfassung

Felix Pharmaceuticals Pvt. Ltd. is seeking a senior professional for the Compliance and Technical Services department. The role focuses on reviewing development-stage documentation, analytical methods, validation processes and quality investigations to ensure adherence to regulatory standards.

The candidate will coordinate with external labs and internal teams to maintain compliant practices across AD laboratory areas and participate in self-inspections and internal audits.

Qualifikationen

• Post graduate qualification in Pharmacy or Chemistry Pharmaceuticals (API & Formulations).
• Experience of 8 to 10 years in analytical R&D, QC and QA support.
• Sound knowledge of Quality Management Systems including change controls, CAPA and deviations.
• Exemplary verbal and written communication skills.
• Proficient with MS Word, Excel (validated spreadsheets), PowerPoint and related software.

Aufgaben

• Review specifications and STPs for Raw Materials, Intermediates, in-process controls, Drug Substances and Drug Products.
• Evaluate analytical test methods for adequacy before validation and assist method validation/verification.
• Coordinate with external labs/CROs/CMOs for compliance and technical requirements.
• Monitor and implement good practices in laboratory areas and participate in internal audits.

Jobbeschreibung

Department- COMPLIANCE AND TECHNICAL SERVICES

Experience Minimum of 8 to 10 years

Field Qualification Post Graduate in Pharmacy or Chemistry Pharmaceuticals (API & Formulations) in areas of Analytical R&D, QC and QA

1. Review of the following at different phases of product development process:
   1. a) Specifications and STPs of Raw Materials, Intermediates, In-process Controls, Drug Substances and Drug Products.
   2. b) Analytical test methods for their adequacy and intended use before initiation of validations.
   3. c) Analytical method validation/verification protocols and reports.
   4. d) Analytical method development report and method suitability / pre-validation reports.
   5. e) Analytical method transfer protocols and reports.
   6. f) Analytical Laboratory Investigations, non-conforming materials, other quality investigations and quality deviations (Planned Temporary Changes) dealing with the materials or activities.
   7. g) Cleaning validation protocols and reports.
   8. h) Instrument / equipment calibration data and reports.
   9. i) Instrument / equipment qualification protocols, data, and reports.
   10. k) SOPs and guidelines of different departments for their adequacy to requirements and good laboratory practices.
   11. l) Laboratory Notebooks and associated data.
   12. m) Stability protocols and stability reports.
   13. n) Use period and extension of shelf-life documentation based on available stability data
2. Awareness of all documentation processes and having sound knowledge pertaining to Quality Management Systems including, but not limited to:
   1. a) Change Controls
   2. b) Incident/Deviation Investigations
   3. c) Corrective and Preventive Actions (CAPA)
   4. d) Planned Deviations or Planned Temporary Changes
   5. e) Technical Excursions
3. Coordinating with external labs / CROs / CMOs and / or subject-matter-experts for various matters pertaining to compliance and technical requirements
4. Review, monitoring and implementation of compliance and good practices in AD laboratory areas.
5. Assessment of self-inspections and participation in internal audits.
6. The candidate must have exemplary verbal and written communication skills.
7. The candidate must have good working knowledge of computers
8. & related software (especially MS Word, Excel (including validated spreadsheets), Power Point etc.) is mandatory.