Executive QA
Date: Oct 4, 2024
Location: Ahmedabad, GJ, IN, 382110
Company: Actylis
Actylis is a leading manufacturer and supplier of critical raw materials and performance ingredients serving the Life Sciences, Specialty Chemicals, and Agriscience industries.
We offer standard and custom ingredients through our rapidly growing portfolio of GMP and non-GMP facilities worldwide, and further choice through our strong sourcing hub network. This unique hybrid option blending manufacturing and global sourcing, combined with more than 75 years of sourcing and distribution experience makes Actylis the Partner of Choice.
Position Summary
This role define the complete handling and monitoring of QA department QMS activities, which includes management of complete quality system starts from document and data control, further include Change management, complaint management, deviation management, customer and regulatory audit handling and compliance writeups. The persons in the QA QMS section will also ensure audit readiness customer compliance and regulatory compliance. Will take the lead in completing the internal audits and manage the management review meetings. This role is will have extended responsibility in product release, registration and new product development and launches related to Quality responsibility.
Responsibilities will include:
Preparation, compilation, and approval of APQR of all products wherever applicable.
Equipment/Instrument /Utility Validation and documentation management.
Review and management of Batch Manufacturing records master document for PR-01, PR-02 and PR-03 production department.
Management of Change controls i.e. insurance, review, compilation, and life cycle management of change controls of whole site per change management procedure.
Management of Market complaint for Pharma excipient and LC products from start of complaint acknowledgement, receipt, investigation, handling of complaint sample till the closure of the complaint.
SAP item master creation, BOM updates and other critical transactions related to Pharma excipient products.
Quality Matrix Monthly/Quarterly/Half yearly and Annual preparation and compilation.
Monthly trend preparation of complaint per the procedure.,
Management and procedural execution of Management review meeting.
Management of different technical service providers per the procedures,
Aqua product license management and life cycle handling.
Audit and compliance management of customer and regulatory bodies.
Management of internal audit and its compliance.
Required Experience & Knowledge
B.Pharma/M.Pharma, Msc. Chemistry, Btech or Mtech with biotechnology or chemistry.
Experience
5-6 years of experience in Pharmaceutical, API or excipient regulated industries.
Supervisory Responsibilities
No
Actylis is an Equal Opportunity Employer. Actylis US does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided based on qualifications, merit, and business need.