Quality Assurance Head - API - Mahad

Role & responsibilities

To ensure that Quality Policy and applicable policies are implemented at Site.

To comply and follow the requirement of cGMP & other applicable policies are available at Site.

Authorize the release of Finished Product to the Market.

Establishing a system to retest/ release/ reject raw materials, intermediate, packing and labeling materials.

Ensuring that the completed batch manufacturing and Analytical testing records are reviewed before release of the API for distribution to the market.

Ensure all the deviations, change control, incidences and OOS, OOT are investigated and closed within time.

Review and approval of QMS Document i.e. Change Control, Deviation, Market Complaint, OOS/OOT, Return Goods, Product Recall and CAPA.

Approving all specifications, Master formula Records, Batch manufacturing records, and its related documents.

Ensuring data integrity and implementation of ethics policy.

Approving all the Standard Operating Procedures, Protocols, Reports of Titan Pharmaplus Pvt. Ltd.

Perform the Internal Audits (Self Inspections) as per approved schedule, Audit findings and its CAPA are completed in a timely manner.

Perform the audits of Contract Testing labs, Key Starting Material and Primary Packaging Material vendors and provide the approval/ rejection to Contract Testing labs or vendors.

Review and approval of Vendor qualification documents.

Reviewing and approving Qualification/ Validation protocols and reports.

Making sure that effective system is used for maintaining and calibrating of critical equipment.

Performing product quality review as per the SOP.

Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs wherever appropriate.

Making sure Raw & Packing Material suppliers are qualified and approved as per the SOP.

Approval of reprocessing for Intermediates and API.

Responsible for GMP training to all personnel.

Responsible to make site all time readiness for regulatory and customer audits.

Coordination in Quality Risk Management.

Preferred candidate profile

1. Good knowledge of process of API manufacturing w.r.t. type of reactions.

2. QMS

3. Qualification and Validation

4. Inprocess Technics

5. QC (OOS / WT and laboratory insider)

6. Technology Transfer

7. Audits exposure (Regulatory)