Assistant Manager/Deputy Manager

Job Title: Assistant Manager/Deputy Manager Department: DQA
Reports to: GM

Job Summary, Duties/Responsibilities:
Ensure proper guidance on quality issues to the Product Development Teams
• Review the documents received from R&D, AR&D, etc. so that the same can be shared with authorities and customers
. coordination communication and to respond customer complaint/query and regulatory authority.
• Review the process change proposals and help the team members provide guidance on change proposals
• Review the in-house expert reports/Quality overall summary (QOS) prepared by the team members
• Ensure proper stage gate compliance at various stages of product development
• Ensure that internal audits are conducted properly
• Review the developmental reports and other documents
• Ensure appropriate qualification of API.
• Ensure appropriate qualification of external manufacturing sites
• Ensure self-inspection programs are conducted properly across R &D.
• Review the existing GMPs, STPs, GLPs or SOPs and update them if required
• Help the team members manage change controls, deviations, incidents
• Ensure international customers audits, regulatory audits, etc. is handled in a suitable manner
• Ensure proper maintenance of central documentation, i.e. the Development Quality Assurance (DQA) document cell
• Support audits/ quality investigations issues of other Business units
• Ensure thorough Inspection of quality till the exhibit batch stage
• Ensure quality by design, i.e. ensure robustness of product and process



Required Skills/Abilities:
Working experience in QbD and other new ICH, FDA guidelines.
Education and Experience:
Required Education: M.Sc or M.Pharm or equivalent.
• Minimum Experience:
12+ years of experience in DQA/QA
Candidates with analytical background are preferred.
Shall be well versed with ICH guidelines.
Prior experience of Gap assessment and Remediation activities are preferred.
Preparation of S.O.Ps and shall be ensured the adherence of both R&D and AR&D
Handling of audits including customer audits and regulatory audits.
Response to be provided for audits, customer queries and regulatory queries.
Coordination with Quality control, Quality assurance and Manufacturing teams for the method transfers, scale-up, development activities and during Technology transfers.