Job Description

Department: QA


Location: Ahmedabad



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.



About Actylis:
Over the last 70 years, Actylis has established itself as a leading value-added global chemical supplier specializing in specialty chemicals, nutritional ingredients, and products used across the pharmaceutical value chain including reagents and process aids, intermediates, APIs, and excipients. Actylis' operations span ten countries including the US, Canada, China, India, France, Germany, Netherlands, Ireland, and Singapore. Our global network and staff specialize in 6 core competencies, viz. R&D, Production, Quality Assurance, Supply Chain, Global Sourcing, and Regulatory Compliance. This set of competencies enable agility and choice for our customers, so that they can more rapidly develop and commercialize their innovative products and supply them dependably to their customers.



Key Duties & Responsibilities : :


QMS Section



• 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 transections 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.

• Management of all CAPA for internal and external audit, including CAPA taken against any investigation with tracking, effectiveness verification and closure.

• Specification, MOA and Analytical Data Sheet - Preparation, review cycle, relative update, final sign off, Life cycle management and Mapping in SAP of the prepared specification of all pharma business.

• Management of all CAPA for internal and external audit, including CAPA taken against any investigation with tracking, effectiveness verification and closure.

• Marketing request handling and resolution for Pharma - CoA, comparison sheets with customize CoA, Query resolution and assessment from customers.

• Management of all quality system documents but not limited to SMF, IMS , VMP ect

• To be responsible for batch release of finished products



Documentation section-QA:



• Issuance, retrieval including life cycle management of all GMP documents but not limited to Master copy, control copy, log books and executionary records per site documentation and data control procedures and maintenance.

• Managements of documents in Master control software as a doc controller.

• To perform indent of logbooks from the service provider against the request.

• Management of Stability program of the Pharma products- Scheduled monitoring, preparation of stability protocol, review and compilation of stability reports, to be part of OOT investigation in case of Stability product OOT failure



Food Verticals:



• Release of Lab, Food and Aqua products.

• SAP related transactions, updates and item master creation for LC products, Food Products, Aqua and stream products.

• Customer documentation compliance i.e. VQ questionnaire and sample management for Food, LC and Aqua products business.



Education :

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.


Competencies & Skillset :




Functional / Technical




Behavioral



• Technical writing skills



• Document and data management skills



• Investigation tools and RCA tools knowledge



• Audit handling and auditing skills



• Technical knowledge of API/Excipient/Pharma manufacturing and packaging



• SOP writing and review skills



• Training and management skills


• Good communication skills



• Soft spoken and confident.



• Must have people handling and cross functional convincing and debating skills.




Supervisory Responsibilities:Yes / No