Head - Quality Assurance - Pharma

a. Desirable to have a PhD / MSc (Organic Chemistry) with 20 to 25 years

b. Should have good understanding of Quality Management systems, Process development and Analytical development, QC Lab, Manufacturing, Engineering, Supply chain management and Packaging

c. Should have extensive exposure to regulatory and customer audits

d. Should be able to recruit, train and implement quality skills in QA personnel

e. Should be able to identify and deliver training to fulfil needs of manufacturing facilities

f. Should have experience in managing audits in a leadership role

g. Hands on approach, energetic, hardworking, meticulous with attention to details

h. Should have strong interpersonal skills and ability for conflict resolution

i. Strong exposure to computer systems assurance, data reliability and data integrity

j. Ability to work closely with Head of R&D, Senior Leaders in Process and Analytical development

k. Review and approval of Quality documents (Specifications, Test methods, SOPs for R&D, validation reports, and documents related to testing license procurement).

l. Review and approval of validation, qualification protocols, and reports at R&D.

m. Responsible for establishing the change control system, review, and also approving authority.

n. Responsible for review and approval of documents such as Site Master File, Quality Manual, etc.

o. Responsible for development and approval of vendors, vendor audits in coordination with purchase department and corporate QA.

p. Responsible for document and data control which includes storage and retrieval of documents and records.

q. Responsible for the implementation of GLP and Quality Systems in coordination with related departments.

r. Responsible for ensuring that R&D investigations of critical deviations and plant-related OOS are conducted in adherence to GLP/GMP regulations.