DGM/ AGM- Quality Assurance: Formulations require in Tidal Labs

Tidal was incorporated in the year 1995, with the backbone of a strong professional team with true commitment to healthcare profession. Operation began modestly in two states, Maharashtra and Karnataka, with a team of 40 medical representatives The product basket was limited, the team was young and the market was intensely competitive- yet, they had an urge to create something perpetual and everlasting, and were determined to use their own mental, financial, physical and entrepreneurial skills to realize their dream.

Post : DGM/ AGM- Quality Assurance: Formulations

Job Description:
The candidate will be responsible for the entire gamut of Quality Assurance Dept. activities of the Organisation.
Role & responsibility and KRAs:
1) To provide leadership in the development and continuous improvement of the documentation and data management processes.
2) To lead the definition, development and delivery of Quality products and in accordance with GMP standards.
3) To manage team of QA Analysts in review, certification and release of product batches.
4) Review batch records to ensure that all steps have been performed and verified, that all limits and specifications have been met and that the raw materials have been tested and released.
5) Perform technical and quality reviews of on site manufacturing sites related to the design, validation, operation and maintenance of processes, equipment and facilities to ensure compliance with international GMP regulations and standards.
6) Investigate and timely resolve quality and testing related issues and discrepancies.
7) Provide compliance oversight and review of manufacturing/packaging batch records and analytical release testing data according to Standard Operating Procedures (SOPs).
8) Manage the technology transfer for new formulations.
9) Support regulatory agency submissions. Update and co-ordinate with agencies to get accreditation.
10) To identify and implement Continuous Improvement.
11)To ensure that the appropriate validations, including those of analytical procedures and calibrations of control equipments are carried out on timely basis
12) Analyze, plan & conceptualize the processings for the product development while coordinating with the product development & cross-functional sales and marketing teams.

Candidate Profile:
The candidate must ideally be a Doctorate or Masters with 15 years experience in Quality Assurance of Pharma Formulations possessing excellent skills in documentation, validation, microbiology, stability studies & regulatory affairs.
He must have rich experience of leading a team of QA and QC chemists in the pharmaceutical formulation facility. Exposure to Latest International guidelines viz. WHO/ MHRA etc is required.Experience with contract operations and implementation of quality systems is an added advantage.
Finally, The candidate must have a strong commitment to individual and team development with particular emphasis on delivery of Quality Training. He must be able to bring about increased quality consciousness in every department of the factory.

Additional Information:
Experience: min. 15 years
Location: bhakra nagal, himachal pradesh
Education: B.Pharm, B.Sc, MBA
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA