Quality Assurance Officer jobs in Ahmedabad at Contract Pharmacal Corporation India Pvt Ltd

Job Description:

To review documentation of manufacturing and packaging.

Retrieve electronic scans and review batch records based on CGDP, cGMP, CPC’s SOPs, and FDA guidelines.

To perform batch data entry for APR and process validation.

Preparation of Annual Product Review / Product Quality Review reports.

To review the process validation report.

Required Skills:

Ability to read and interpret FDA guidelines as they

apply to documentation reviews. Knowledge of cGMPs related to US FDA and EU EMEA manufacturing environments.,

Knowledge of manufacturing and packaging processes.

Proficiency in Microsoft Word, Excel, graphs/charts, and databases.

Ability to communicate effectively.

Ability to compile, organize and track documentation.

Detail-oriented, with excellent proofreading skills, and the ability to multi-task in a fast-paced environment.

Contract Pharmacal Corporation India Private Limited (CPC India) is a wholly owned subsidiary of CPC USA and engaged in the formulation development, analytical development and regulatory services. The state of art research centre is home to 35 highly skilled and experienced scientists capable of developing challenging formulation for all different regulated market. CPC India provides full services from concept to commercialization with best quality and competitive pricing.

CPC provides the following services to customers

1. Formulation development for USA, Europe and other regulated markets

2. Analytical development and validation

3. Manufacturing of oral solid dosages

4. Packaging of oral solid dosages

5. Stability testing

6. Regulatory dossier compilation and publishing in the eCTD format

7. cGMP compliance audits for API, raw material and finished product manufacturing facilities

8. Potent products (Hormones and Steroids etc.) and controlled substances