Job as QC/ Analytical Supervisor /Manager in Chantilly BioPharma

Chantilly BioPharma Pvt Ltd., (VenKOR Specialty Products) is a subsidiary of USA Pharmaceutical Company, a Drug Development Company.

Post: QC/ Analytical Supervisor / Manager

Job Description
Scope: Analyses of oral solid dosage forms, liquids, soft gels, microencapsulation’s, materials and intermediate ingredients. As per USP, ICH and US FDA standards, methods development, validation, equipment qualifications, the quality control provides support to the quality control department by performing functions, which aid assurance of GMP compliance. The quality control is responsible for assisting with quality control operations are performed according to written Sop’s, GMP and FDA guidelines. Additionally, the quality control is responsible for assisting in development and implementation of quality control systems and procedures.

Duties/Responsibilities:
• Maintain and follow cGMP practices.
• Preparation of standard operating procedures, for quality control activities
• Developing test methods or procedures and preparing the specifications and release specifications.
• Sampling and testing of all input raw materials, packaging material, in process tests and finished dosage forms.
• Calibration and maintenance of various instruments used in testing or analysis.
• Conducting stability studies.
• Providing support to validation activities.
• Training laboratory staff in line with GMP.
• Recording, reviewing and investigating out of specification results from the laboratory control mechanisms.
• Maintaining the reserve samples for raw materials, product contact materials and finished dosage forms.

Candidate Profile
Technical Skills: (Include certifications – use separate sheet if necessary) Minimum Bachelor’s Degree in Science, prefer Masters degree in Analytical chemistry or Pharmaceutical Analysis. With experience of minimum two years, prefer five years in Pharmaceutical product development or related fields.
• Knowledge of cGMPs, quality systems and other FDA regulatory guidelines for drugs.
• Ability to prepare and identify own departmental Sop’s.
• Ability to organize

Job Related Behavioral Skills: (Include musts and wants. Use separate sheet if necessary) Must be able to work in a fast paced environment, detail oriented, able to multi-task, team player as well as work independently.

Additional Information:
Education: M.Pharma, B.Pharma, M.Sc, B.Sc
Industry Type: Pharma
Functional Area: QC
Location: Hyderabad