General Manager - Corporate QA

Role & responsibilities

• Should have hands on experience in developing, implementing and auditing quality systems in the organisation as well as preparation of Quality manual, APQRs, SMF and MVP etc.
• Should have experience of actively leading the site team during WHO audits (CDSCO) and foreign regulatory audits viz. Nigeria, Ghana, Tanzania, Kenya. etc.
• Should be well versed with the cGMP guidelines and WHO TRS requirements.
• Must have thorough knowledge for Stability studies, self-inspections, validations, vendor evaluation & development.
• Have knowledge of chemical analysis and instrumentation applicable in the QC and GLP implementation at sites.
• Work also involves knowledge of export registrations of our products and efficient handling of technical documents, dossiers and queries from Export Department.
• Develop and enforce corporate quality assurance policies, SOPs, and best practices across all facilities.
• Lead investigations into critical quality deviations, Change control, Risk assessment, OOS/OOT results, and handling product complaints.
• Have adequate knowledge for preparation DQ/IQ/OQ/PQ of the utilities and manufacturing and packaging equipments ( Non sterile)
• To monitor the Quality of the products and oversee the laid down quality systems effective at the loan licence manufacturing sites.
• Advise the Management from time to time on new developments/ updation in the QA/Regulatory work areas.

Preferred candidate profile

• Lead the CQA and Site QA team and ensure the smooth implementation of procedures and practices at Locations.
• Should have a bachelors/ master's degree in Pharmacy
• The person must have experience of atleast 20 years in QA (preferably at manufacturing sites) and worked at least for 5 years in similar or equivalent position at corporate office in reputed organisations mfg. pharmaceutical dosage forms, cosmetics & nutraceuticals with a proven record of accomplishment.
• Candidate may have to travel extensively to our plants and contract manufacturing locations on regular basis for monitoring activities with the aid of Site QA cells.
• Position reports to Director